Medibulk [Discontinued] by Thorne Research

POSSIBLY EFFECTIVE

• Constipation. Most clinical research shows that oral inulin modestly improves stool frequency, but may not improve discomfort, in adults and children with constipation. Details: A meta-analysis of clinical research in adults with constipation shows that consuming inulin improves stool frequency by approximately 0.7 stools per week. It also seems to improve stool transit time, consistency, and hardness, but does not reduce pain or bloating (93718). Additional clinical research shows that taking a specific type of inulin (OraftiGR, BENEO GmbH) 12 grams daily in three divided doses for 4 weeks increases stool frequency by approximately one stool per week when compared with a maltodextrin control. Taking inulin also reduces the number of patients experiencing hard and lumpy stools by 13%, but does not improve symptoms of bloating, distension, physical discomfort, or gas (96850). In children aged 2-5 years, one small clinical study shows that taking a specific combination of two inulin products (Orafti P95 oligofructose and Orafti GR inulin, BENEO GmbH), 2 grams twice daily in a dairy liquid for 6 weeks, improves the softness of stools, but not pain with stooling or stool frequency, when compared with a maltodextrin control (96848). Research in older adults is conflicting. One small study shows that taking inulin 20-40 grams daily for 19 days increases the number of stools from 1-2 per week to 8-9 per week (10415). However, other preliminary clinical research in this population shows that taking a specific inulin supplement (Fibruline Instant, Cosucra Groupe Warcoing) 15 grams daily in yogurt or stewed fruit for 4 weeks does not improve bowel symptoms, stool frequency, or stool consistency (93724).
• Diabetes. Short-term use of oral inulin along with antidiabetes drugs may improve glycemic control in some patients with type 2 diabetes; however, the benefits of long-term use are unclear. Details: Two meta-analyses of clinical research in normal weight and obese patients with type 2 diabetes show that taking inulin 0.8-10 grams orally daily for 6-12 weeks reduces glycated hemoglobin (HbA1c) by 0.65% and fasting plasma glucose by 16 mg/dL when compared with control. Taking inulin also improved HOMA-IR, a measure of insulin resistance, when compared with control. Researchers did not evaluate the most effective dose of inulin; however, most studies used 8.4-10 grams daily (103198,105533). In females treated with metformin and glyburide, taking inulin 10 grams daily for 8 weeks reduces fasting blood glucose by 15 mg/dL and HbA1c by 1% when compared with placebo (93719). Population research in adults has also found that high dietary intake of inulin over 8 years of follow up is associated with a 6% lower risk of type 2 diabetes when compared with low dietary intake (110515). Inulin has also been studied in combination with other supplements. Preliminary clinical research in elderly patients with diabetes shows that drinking a milk powder product supplemented with inulin and resistant dextrin 30 grams before breakfast and 15 grams before dinner for 12 weeks decreases fasting plasma glucose by 17 mg/dL, HbA1c by 0.38%, postprandial glucose by 27 mg/dL, body weight by 0.8 kg, and systolic and diastolic blood pressure by 5 mmHg when compared with placebo (99843). Other clinical research in adults with type 2 diabetes shows that taking a specific combination product (Orafti Synergy1, BENEO GmbH), containing 50% inulin and 50% fructo-oligosaccharides, 8 grams orally twice daily for 6 weeks does not reduce body weight or caloric intake or increase satiety scores when compared with placebo (107934).
• Obesity. Oral inulin might modestly improve short-term weight loss. Additional research is needed to determine the long-term effects of inulin on weight loss and weight maintenance in overweight or obese individuals. Details: Some clinical research in overweight and obese females with diabetes shows that taking inulin 10 grams daily for 8 weeks results in weight loss of 2.6 kg, compared with no weight loss in those taking placebo (93719). Preliminary clinical research in overweight or obese patients with prediabetes shows that taking a specific brand of inulin (Orafti Synergy 1, BENEO GmbH) 30 grams orally daily for 6 weeks reduces body weight by 0.4 kg, compared with a 0.4 kg increase in those in the control group (93721). Preliminary clinical research in adults with obesity shows that taking inulin 16 grams orally daily for 3 months moderately reduces body weight and body mass index (BMI) when compared with placebo. However, these effects were most prominent in subjects that also increased physical activity (110514). Additional preliminary clinical research in adults with overweight shows that adding 18 grams of inulin powder to green tea daily increases weight loss when compared with green tea alone. Over six weeks, individuals taking inulin lost 2 kg, compared with no weight loss in those taking green tea. Weight loss was maintained for at least 2 weeks (93726). Clinical trials in children show conflicting results. In children aged 7-12 years, a small clinical study shows that taking a specific oligofructose-enriched inulin product (Orafti Synergy1, BENEO GmbH) 8 grams orally in water before one meal daily for 16 weeks decreases weight gain by 2.4-fold and attenuates an increase in BMI when compared with placebo (96847). However, other preliminary clinical research in children with obesity aged 7-15 years shows that taking inulin extract 13 grams orally daily for 6 months does not reduce body weight or BMI when compared with placebo (110598). However, other clinical research shows that taking inulin orally in combination with other ingredients might not improve weight loss. Combining inulin, chromium picolinate, capsicum, L-phenylalanine, and other nutrients with caloric reduction and exercise doesn't seem to reduce weight in moderately obese patients when compared to caloric reduction and exercise alone (7607). Another preliminary clinical trial shows that taking inulin 10 grams with maltodextrin 10 grams daily for 12 weeks does not reduce body weight or improve body composition when compared with placebo in adults with overweight or obesity following a calorie-restricted diet (103202). Preliminary clinical research in adults with obesity also shows that consuming a seafood-based dietary product fortified with inulin 1.7 grams, fish oil 370 mg (containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and bifidobacterium animalis daily for 12 weeks does not lower body weight, waist circumference, abdominal fat, serum cholesterol levels, or blood pressure when compared with placebo. However, consuming the product modestly improved some markers of insulin resistance (110600).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alcohol use disorder. It is unclear if oral inulin is beneficial in patients with alcohol use disorder. Details: Preliminary clinical research in adults with alcohol use disorder who were recently admitted to the hospital shows that taking a specific inulin product (Fibruline, Cosucra) 4-16 grams orally daily for 17 days does not improve liver function tests when compared with placebo. Some liver function tests were also worse in those treated with inulin (110601).
• Antibiotic-associated diarrhea. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children aged 6 months to 14 years receiving antibiotics for common infections shows that taking a combination of inulin and fructo-oligosaccharides, up to 5 grams daily depending on age, does not reduce the rate of antibiotic-associated diarrhea (93720).
• Celiac disease. Small clinical studies suggest that patients with celiac disease who take oral inulin may have a lower risk of vitamin and mineral deficiency. Details: Preliminary clinical research in a small number of children and adolescents with vitamin and mineral malabsorption due to celiac disease shows that taking a specific oligofructose-enriched inulin product (Orafti Synergy 1, BENEO GmbH) 10 grams daily for 3 months improves the absorption of vitamin D, vitamin E, and iron, but not vitamin A (99841,99842). Levels of 25-hydroxy vitamin D and vitamin E increased by 42% and 19%, respectively, compared with no significant improvements in those taking placebo (99842). Although taking inulin did not improve serum ferritin levels, it did decrease serum hepcidin concentrations by 61% when compared with baseline, while no significant improvement was reported with placebo. Hepcidin is a regulator of iron homeostasis, and increased levels are associated with iron-deficiency anemia (99841).
• Child growth. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in healthy, exclusively formula-fed, infants less than 4 months of age shows that supplementing formula with 0.8 grams/dL of a specific combination product (Orafti Synergy1, Beneo-Orafti) containing 50% inulin and 50% fructo-oligosaccharide until 12 months of age does not improve markers of child growth, including body weight, length, and head circumference, when compared with placebo. The combination product was associated with a reduced duration of fever during infectious episodes, but not with a reduction in the number of infections. It is unclear if any potential effects are due to inulin, fructo-oligosaccharide, or the combination (107937).
• Chronic kidney disease (CKD). It is unclear if oral inulin is beneficial in patients with CKD. Details: In adults with CKD, adding inulin 19 grams daily for 6 months to a low-protein diet reduces serum insulin, fasting plasma glucose, total serum cholesterol, triglycerides, and markers of systemic inflammation, while increasing serum high density lipoprotein (HDL) cholesterol, when compared with baseline (105534). However, it is unclear if similar changes occur with a low-protein diet alone, or if the rate of progression of CKD is reduced. Population research in adults has found that high dietary intake of inulin over 8 years of follow up is not associated with a lower risk of CKD when compared with low dietary intake (110515).
• Hypercholesterolemia. It is unclear if oral inulin reduces cholesterol levels in patients with hypercholesterolemia. Details: Research in patients with hypercholesterolemia has shown mixed results, with some studies showing a small decrease and others showing no improvement in serum cholesterol levels (7604,8450,10412,10413,96849). A typical dose of inulin used is 6 grams orally three times daily for up to 6 weeks (10412). A meta-analysis of healthy, dyslipidemic, overweight or diabetic patients shows that inulin reduces levels of low-density lipoprotein (LDL) cholesterol by approximately 5% (96849). Another meta-analysis of randomized clinical trials in the same population shows that taking inulin 1.5-30 grams daily for 2-12 weeks reduces LDL cholesterol levels by 7 mg/dL and increases high-density lipoprotein cholesterol levels by 2 mg/mL when compared with control. However, this meta-analysis also included data from patients treated with fructo-oligosaccharides instead of inulin (107940).
• Hypertension. It is unclear if oral inulin is beneficial in patients with hypertension. Details: Population research in adults has found that high dietary intake of inulin over 8 years of follow up is associated with a 21% lower risk of hypertension when compared with low dietary intake (110515).
• Hypertriglyceridemia. It is unclear if oral inulin is beneficial in patients with hypertriglyceridemia. Details: A meta-analysis of clinical trials in normal and moderately hyperlipidemic patients suggests that taking inulin-type fructans at an approximate average dose of 14 grams daily reduces triglyceride levels by about 15 mg/dL when compared with control (93737). However, other research, including a meta-analysis of healthy, dyslipidemic, overweight or diabetic patients shows that taking inulin 1.5-30 grams daily for 2-12 weeks does not reduce triglyceride levels when compared with control. However, these negative studies are limited by small sample sizes and inclusion of data from patients treated with fructo-oligosaccharides instead of inulin (7604,107940).
• Impaired glucose tolerance (prediabetes). Several small clinical studies suggest that oral inulin is not beneficial in patients with prediabetes. Details: Preliminary clinical research in adults with prediabetes shows that taking inulin 15 grams orally daily for 24 weeks does not improve fasting blood glucose, glycated hemoglobin (HbA1c), or lipid levels when compared with placebo. However, taking inulin modestly improved markers of insulin resistance (107938). Two other, small, clinical trials show that taking specific inulin products (Orafti Synergy 1, BENEO GmbH or Frutafit IQ, Sensus American) 10-30 grams daily for 6 weeks does not improve blood glucose, insulin resistance, glucose homeostasis, or insulin sensitivity when compared with placebo (93721,107936). However, these studies may have been inadequately powered to detect a difference between groups.
• Iron deficiency anemia. Oral inulin has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in young adult females with iron deficiency anemia shows that taking inulin 963 mg/kg and iron supplementation orally daily for 3 months modestly improves serum hemoglobin, hematocrit, and iron levels when compared with a control group consuming iron-fortified flour (110599).
• Menopausal symptoms. It is unclear if oral inulin is beneficial in patients with hypertriglyceridemia. Details: Preliminary clinical research in adults experiencing menopause shows that consuming yogurt enriched with a specific inulin (Frutafit TEX, Sensus Company) 1.5% daily for 6 weeks moderately improves menopausal symptom scores, including depression, anxiety, and vasomotor symptoms, when compared with yogurt alone (107659).
• Nonalcoholic fatty liver disease (NAFLD). Taking oral inulin alone does not seem to improve liver transaminase levels in patients with NAFLD. Details: Preliminary clinical research in patients with NAFLD shows that taking metronidazole 400 mg twice daily for one week plus inulin 4 grams twice daily for 12 weeks reduces levels of alanine aminotransferase and aspartate aminotransferase when compared with placebo. However, when inulin is taken without metronidazole, these measures are not improved (103200).
• Polycystic ovary syndrome (PCOS). It is unclear if oral inulin is beneficial in patients with PCOS. Details: Preliminary clinical research in overweight or obese females with PCOS shows that taking specific products containing inulin (FrutaFit TEX, Sensus American) or inulin and fructo-oligosaccharides (FrutaFit IQ, Sensus American) 10 grams orally once daily for 12 weeks does not reduce systolic or diastolic blood pressure when compared with placebo. However, the validity of this study is limited by the inclusion of subjects with and without hypertension at baseline (107941). More evidence is needed to rate inulin for these uses.

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POSSIBLY EFFECTIVE

• Hypercholesterolemia. Most clinical research shows that oral pectin at a dose of 15 grams daily can slightly lower total cholesterol and low-density lipoprotein (LDL) cholesterol levels in patients with hypercholesterolemia. Details: While some small studies in patients with or without hypercholesterolemia suggest that pectin 1-12 grams daily for up to 12 weeks does not reduce lipid levels (2215,2217), other research in patients with hypercholesterolemia shows that taking pectin 15 grams daily for 4 weeks consistently reduces total cholesterol and LDL cholesterol by around 7% to 10% when compared with baseline or placebo (2214,2216,92473). Some forms of pectin might lower cholesterol levels better than others. Pectin with a higher molecular weight and higher degree of esterification appears to be the most effective (92473). A larger clinical study also shows that taking 20 grams of pectin and guar gum, along with small amounts of insoluble fiber, reduces total cholesterol by nearly 8% and LDL cholesterol by nearly 11%, but does not improve high-density lipoprotein (HDL) cholesterol or triglycerides, when compared with placebo (12547).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Colorectal cancer. Although there has been interest in using oral pectin for the prevention of colorectal cancer, there is insufficient reliable information about the clinical effects of pectin for this purpose.
• Diarrhea. It is unclear if oral pectin is beneficial in children with persistent diarrhea. Details: A small clinical study in children aged 5-12 months in developing nations with persistent diarrhea shows that taking pectin 4 grams/kg reduces the duration of diarrhea and vomiting, and reduces the need for oral rehydration solution and intravenous fluid, when compared with a rice-diet control (12575). Pectin has also been evaluated in combination with other ingredients. One clinical study in children aged 6 months to 6 years with acute diarrhea shows that taking a combination of apple pectin and chamomile (Diarrhoesan, Dr. Loges + Co. GmbH) for up to 5 days reduces the frequency of stools by day 3 by about 1.36-fold when compared with placebo, with improvements maintained through day 5. This combination product was given hourly up to a maximum dose of 50 mL in children 6-12 months of age, 60 mL in children 1-3 years of age, and 80 mL in children 4-6 years of age (19705). It is unclear if these findings are due to pectin, chamomile, or the combination.
• Gastroesophageal reflux disease (GERD). It is unclear if oral pectin is beneficial in children with GERD. Details: A small clinical study in children with GERD and cerebral palsy shows that adding pectin to enteral nutrition in a 1:2 ratio for 4 weeks might reduce some symptoms of GERD. The number of vomiting episodes per week was reduced by 60% and the frequency of coughing/wheezing was reduced by 76% for children given the pectin diet when compared with those given a non-pectin diet (92476).
• Impaired glucose tolerance (Prediabetes). It is unclear if oral pectin is beneficial in patients with impaired glucose tolerance. Details: A small clinical study in middle-aged patients with impaired glucose tolerance or impaired fasting glucose shows that drinking 400 mL of a beverage containing 40 grams/L of sugar beet pectin in two divided doses daily for 12 weeks does not improve fasting or postprandial plasma glucose concentrations or serum lipid levels when compared to baseline (34118).
• Irritable bowel syndrome (IBS). Although there has been interest in using oral pectin for IBS, there is insufficient reliable information about the clinical effects of pectin for this purpose.
• Mercury toxicity. It is unclear if oral pectin is beneficial in patients with mercury toxicity. Details: A small clinical study in children with mercury poisoning shows that taking pectin 2.5 grams daily for 21 days and then 5 grams daily for 39 days increases mercury excretion in the urine, decreases the duration of mercury toxicity, and improves psychological symptoms when compared to baseline (31657). The validity of these findings is limited by the lack of a comparator group.
• Niacin-induced flushing. It is unclear if oral pectin is beneficial for the prevention or management of niacin-induced flushing. Details: A small clinical study shows that taking apple pectin 2 grams 30 minutes prior to taking niacin extended-release 1000 mg reduces the duration of flushing by about 35 minutes when compared with placebo. However, apple pectin does not reduce the incidence of flushing, the time to flush, or the maximum severity of flushing (92477).
• Peptic ulcers. It is unclear if oral pectin is beneficial for the prevention of peptic ulcers. Details: A small clinical study in patients with recently healed duodenal ulcers shows that taking apple pectin 10 grams twice daily for 6 months does not reduce the recurrence of duodenal ulcers when compared with placebo (31697).
• Prostate cancer. It is unclear if oral pectin is beneficial in patients with prostate cancer. Details: Two small clinical studies in patients with prostate cancer show that taking a specific modified citrus pectin product (Pectasol, Econugenics) 4.8 grams three times daily following prostatectomy, radiation, or cryosurgery for up to one year slows disease progression and increases the time to prostate specific antigen (PSA) doubling when compared to baseline (15020,108525). The validity of these findings is limited by the lack of a comparator group.
• Radiation exposure. Although there has been interest in using oral pectin to minimize exposure to environmental radiation, there is insufficient reliable information about the clinical effects of pectin for this purpose. More evidence is needed to rate pectin for these uses.

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POSSIBLY EFFECTIVE

• Constipation. Consuming whole dried plums (prunes), plum juice, or plum puree seems to improve symptoms of constipation at least as effectively as psyllium. Details: Clinical research in patients with chronic constipation shows that taking dried plum juice 54 grams daily for 8 weeks modestly reduces the rate of hard and lumpy stools and increases the rate of normal stools at about 3 weeks when compared with placebo. Subjective improvements in constipation and hard stools also occurred by 8 weeks. However, there was no effect on flatulence, loose stools, or feelings of urgent or incomplete defecation (109233). Another small clinical study in patients with certain gastrointestinal symptoms shows that consuming a drink containing dried plum puree and plum juice 125 mL twice daily for 2 weeks increases fecal frequency by 0.6 times per week when compared to baseline (95293). However, the validity of the finding in this study is limited by the lack of a comparator group. Research has also compared dried plums with psyllium. One small clinical study in adults shows that taking dried plums 50 grams twice daily for 3 weeks improves straining and consistency and modestly increases the number of weekly bowel movements when compared with taking an equivalent dose of fiber in the form of psyllium 11 grams daily (95280). Another small clinical study in adults with constipation shows that drinking a specific type of plum juice (PlumSmart, Sunsweet Growers) 240 mL daily 15-30 minutes prior to the main meal for 2 weeks results in a 4.7-fold greater likelihood of relief from constipation within 24 hours when compared with drinking apple juice. Drinking plum juice is equally effective to drinking apple juice containing psyllium. Plum juice also improves stool softness, although it does not increase the weekly number of bowel movements, when compared with apple juice (95294). Clinical research also shows that taking a specific plum-derived mixed fiber supplement (SupraFiber, Sunsweet Growers Inc.) 5 grams dissolved in liquid twice daily after meals for 4 weeks improves symptoms of constipation as effectively as psyllium 5 grams daily. An increase of at least one complete bowel movement per week for at least 2 weeks occurred in 75% of patients in both groups (95275).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dyslipidemia. It is unclear if oral dried plums (prunes) are beneficial in the treatment of dyslipidemia. Details: A meta-analysis of 9 small clinical studies shows that taking plum as either dried plum 11.5-100 grams daily or prune and plum juice 50-250 mL daily for 2 to 12 weeks reduces low-density lipoprotein cholesterol but does not improve total cholesterol, high-density lipoprotein cholesterol, or triglycerides when compared with placebo (112401). The interpretation of these results is limited by poor quality of evidence and heterogeneity due to differences in study populations, design, and amounts and types of plum used. In addition, it is unclear whether patients in all studies had dyslipidemia at baseline.
• Hepatitis. Although there has been interest in using oral plum for hepatitis, there is insufficient reliable information about the clinical effects of plum for this purpose.
• Hypertension. It is unclear if oral plum is beneficial for hypertension. Details: A meta-analysis of 5 small to moderate-sized clinical trials in adults shows that taking dried plum 11.5-23 grams daily for 8 weeks, prune juice 57 grams daily for 2 weeks, or plum juice 200-250 mL daily for 8-12 weeks does not reduce systolic or diastolic blood pressure when compared with placebo (112402). The validity of these findings is limited by low quality of evidence and substantial heterogeneity of the included studies, which enrolled individuals of varying health status and studied different types and regimens of plum. In addition, some studies were in healthy or normotensive patients.
• Obesity. It is unclear if oral plum is beneficial for overweight or obesity. Details: Meta-analysis of 7 small to moderate-sized, moderate-quality clinical trials in adults with normal weight, or overweight and obesity shows that taking dried plum 75-84 grams daily for 8 to 12 weeks or prune or plum juice 50 to 250 mL daily for 4 to 24 weeks does not reduce body weight (112402). Additionally, meta-analysis of 5 of these clinical trialsstudies also shows plum does not reduce body fat percentage (112402).
• Osteopenia. Some preliminary clinical research shows that oral dried plums (prunes) are beneficial for preventing loss of bone mineral density (BMD) in postmenopausal adults. It is unclear if prunes can increase BMD or if they are beneficial for preventing loss of BMD in other populations. Details: Preliminary clinical research in postmenopausal adults aged 55-75 years shows that eating dried plums 50 grams daily for 12 months preserves hip BMD, compared with a modest reduction in hip BMD in adults eating no dried plums. However, there was no benefit on other body sites or on total body BMD. The greatest benefit occurred in individuals with the lowest BMD at baseline. Calcium carbonate and vitamin D3 were supplemented as needed to provide a total intake of calcium 1200 mg and vitamin D3 800 IU from diet plus supplements. This study also evaluated a dose of 100 grams daily; however, there was a high dropout rate in this study arm (109236). The validity of the findings from this study are limited by the mixed population, of which 68% had osteopenia and the remainder had osteoporosis or normal BMD. Other preliminary clinical research in osteopenic postmenopausal adults shows that eating dried plum 100 grams, in addition to taking calcium 500 mg and vitamin D 400 IU, daily for 12 months improves BMD in the ulna by a moderate amount and in the spine by a small amount when compared with consuming dried apple (95276,95278). In the same population also receiving calcium and vitamin D supplementation, consumption of dried plums 50 grams or 100 grams daily for 6 months modestly attenuates total body, but not total hip, lumbar spine, or forearm, losses in BMD when compared with control (95284). Some very preliminary clinical research suggests that this increase in BMD might be maintained for up to 5 years after dried plum consumption (95279). However, research in other populations has not shown benefit. A clinical study in postmenopausal breast cancer survivors shows that consuming dried plums 90 grams daily for 6 months does not improve BMD, muscular strength, or body composition when compared with participating in resistance training and taking calcium 450 mg and vitamin D 800 IU daily (95277). Also, in middle aged and older males, preliminary clinical research shows that eating dried plum 100 grams, in addition to taking calcium 500 mg and vitamin D 300 IU, daily for 12 months does not improve most measures of BMD when compared with not eating plum (109235). However, only some of the patients in this study had osteopenia or osteoporosis.
• Postoperative ileus. It is unclear if oral dried plums (prunes) are beneficial for improving gastrointestinal function after surgery. Details: A small clinical study in females taking docusate sodium 100 grams twice daily after gynecological surgery shows that adding up to 12 dried plums (4 ounces) daily for three days does not reduce the time to first bowel movement when compared with docusate sodium alone. There was also no effect on pain severity with a bowel movement, the need for laxatives, or time to discharge. However, consuming dried plums increased the likelihood of having a bowel movement during the first three days after surgery (109237). The validity of this study is limited by the lack of blinding and its small size. More evidence is needed to rate plum for these uses.

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LIKELY SAFE ...when used orally in amounts commonly found in foods. Inulin has Generally Recognized As Safe status (GRAS) in the US (93728).

POSSIBLY SAFE ...when used orally and appropriately in supplemental doses, short-term. Doses of 8-18 grams daily have been used safely for up to 24 weeks (7604,7605,7606,7607,8451,93716,93719,93726,103200,107936,107935,107938). Also, 20 grams daily has been used with apparent safety for up to 3 weeks (96836,96850). There is insufficient reliable information available about the safety of inulin when used long-term.

CHILDREN: LIKELY SAFE
when used orally in amounts commonly found in foods. Inulin has Generally Recognized As Safe status (GRAS) in the US (93728).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately in supplemental doses, short-term. Clinical studies have used doses of 3-6 grams daily for 10 days in children 3-6 years of age and 5-13 grams daily for up to 6 months in children 7-15 years of age with apparent safety (96847,110598,110602). ...when used in infant formula. A formula containing chicory fructans (Orafti Synergy1, BENEO GmbH), approximately 50% of which were inulin, has been used with apparent safety in infants for 8-12 months (93717,107937).

PREGNANCY AND LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods (93728). There is insufficient reliable information available about using inulin in medicinal amounts during pregnancy or lactation; avoid use.

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LIKELY SAFE ...when used in amounts commonly found in foods. Pectin has Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally in amounts greater than those typically found in food. Pectin 4.8 grams three times daily has been used for up to one year without serious adverse effects (12547,15019,15020,92481,108525).

CHILDREN: POSSIBLY SAFE
when used orally in amounts greater than those found in food, short-term. Pectin 4 grams/kg has been used daily for up to 7 days without reports of serious adverse effects (12575,19705).

PREGNANCY AND LACTATION: LIKELY SAFE
when used in amounts commonly found in foods. Pectin has Generally Recognized as Safe (GRAS) status in the US (4912).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally in medicinal amounts (12577).

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LIKELY SAFE ...when used orally in the amounts typically found in food.

POSSIBLY SAFE ...when dried plums are used orally as a medicine. Dried plums have been used with apparent safety at doses of up to 100 grams daily for up to 12 months (95271,95272,95280,95281,95295,112402,112403). ...when plum juice or dried plum essence is used orally as a medicine. Plum juice has been consumed with apparent safety at a dose of up to 250 mL daily for up to 12 weeks and up to 90 grams daily for 24 weeks (95293,95294,112402). Dried plum essence has been consumed with apparent safety at a dose of up to 100 mL daily for up to 4 weeks (95274,112402).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using amounts greater than those found in food.

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ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, inulin might increase the risk of hypoglycemia with antidiabetes drugs.  Details Some clinical research shows that inulin improves glycemic control in patients with diabetes; however, it is unclear if it has hypoglycemic effects (93719,99843,103198).

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DIGOXIN (Lanoxin) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, pectin might reduce the absorption of digoxin, potentially decreasing its effectiveness.  Details A small clinical study shows that taking digoxin with a kaolin-pectin suspension reduces the absorption of digoxin by about 62% (2212). It is unclear if these effects are due to pectin, kaolin, or the combination.

LOVASTATIN (Mevacor) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, pectin might reduce the absorption of lovastatin, potentially decreasing its effectiveness.  Details Case reports suggest that concomitant use of pectin and lovastatin might reduce the cholesterol-lowering effect of lovastatin, possibly due to reduced intestinal absorption of lovastatin (615).

TETRACYCLINE ANTIBIOTICS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, pectin might reduce the absorption of tetracycline antibiotics, potentially decreasing their effectiveness.  Details A small clinical study shows that taking tetracycline with bismuth subsalicylate in a kaolin-pectin suspension reduces the absorption of tetracycline by about 34% (2213). It is unclear if these effects are due to pectin, kaolin, bismuth subsalicylate, or the combination.

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, plum juice might have antiplatelet effects.  Details Consuming plum juice while taking anticoagulant or antiplatelet drugs might increase the risk of bruising and bleeding. In healthy volunteers, drinking plum juice 200 mL daily for 28 days prolonged clotting time and inhibited platelet aggregation (95304,101248).

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General ...Orally, inulin is well tolerated.
Most Common Adverse Effects:
Orally: Bloating, constipation, diarrhea, flatulence, and gastrointestinal cramps.
Serious Adverse Effects (Rare):
Orally: Anaphylaxis has occurred following consumption of foods high in inulin.

Gastrointestinal ...Orally, inulin may cause flatulence, bloating, diarrhea, constipation, and gastrointestinal cramps, especially at doses over 30 grams (7604,8450,8509,93716,93721,93724,96836,96850,96851,99843)(107936,107940,107941,110602).

Immunologic ...Severe allergic reactions to inulin-containing foods have been reported. There is one report of anaphylaxis following consumption of foods with a high concentration of inulin including salsify, artichoke leaves, and margarine (7608).

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General ...Orally, pectin seems to be well tolerated.
Most Common Adverse Effects:
Orally: Diarrhea, gas, loose stools, and mild cramps.
Serious Adverse Effects (Rare):
All routes of administration: Allergic reactions, including anaphylaxis, in sensitive individuals.

Gastrointestinal ...Orally, pectin alone or in combination with guar gum and insoluble fiber can cause gastrointestinal adverse effects such as mild cramps, diarrhea, gas, and loose stools (12547,15020,92473).

Immunologic ...Orally and topically, pectin may cause allergic reactions in sensitive individuals. In one case, a 7-year-old boy with a history of oral allergy syndrome after consuming a pectin-containing beverage experienced anaphylaxis after taking a citrus bath containing pectin. Allergy testing confirmed sensitivity to pectin (106928).

Pulmonary/Respiratory ...The occupational inhalation of pectin dust can cause asthma (580,581,582,583,584).

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General ...Orally, plum seems to be well tolerated.
Most Common Adverse Effects:
Orally: Gastrointestinal effects, including flatulence and diarrhea.
Serious Adverse Effects (Rare):
Orally: Allergic reactions. Consumption of dried plums or plum pits has been reported to cause bowel obstruction and esophageal perforation.

Gastrointestinal ...Orally, plum has been reported to cause gastrointestinal issues (95272,95276,95285), including flatulence (95293) and diarrhea (95300).
In one case report, small bowel obstruction with impaction in the terminal ileum occurred in a 10-month old infant who consumed a dried plum. This was likely due to the infant being unable to properly chew the plum (95296).
Consumption of plum pits has also caused serious gastrointestinal adverse effects. Ileal obstruction occurred in a 71-year-old female who swallowed a plum pit (101250). In a young male, ileostomy obstruction due to plum pits has occurred (95298). Swallowing a plum pit has also caused an esophageal perforation in a 75-year-old male (95285).

Immunologic ...Orally, plum has been reported to cause allergic reaction in sensitive individuals (95286,95297).

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