Apple Pectin 500 mg [Discontinued] by Nature's Plus

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alzheimer disease. It is unclear if apple juice consumption is beneficial in patients with Alzheimer disease. Details: A small clinical study in adults with moderate to severe Alzheimer disease shows that drinking 4 ounces of apple juice twice daily for one month does not improve cognitive function when compared with baseline. However, according to caregiver assessment, it seems to improve aspects of mood and behavior, such as anxiety, depression, apathy, delusion, and agitation, when compared with baseline (94422). The validity of this finding is limited by the lack of a comparator group.
• Cancer. It is unclear if apple consumption is beneficial for preventing cancer. Details: Some population research has found that eating one or more apples daily may be associated with a decreased risk of esophageal, colorectal, larynx, or breast cancer when compared with eating less than 1 apple daily (31688). Also, a case-control study in adults with lung cancer has found that increased apple consumption may be associated with a reduced risk of lung cancer (3470).
• Dental plaque. It is unclear if apple consumption is beneficial for reducing dental plaque. Details: A small clinical study in healthy patients shows that eating an apple is less effective for reducing plaque than brushing teeth. Eating an apple actually increases plaque when compared with baseline, although it decreases the measure of bacterial vitality (99447).
• Diabetes. It is unclear if consumption of powdered, dehydrated apple is beneficial in patients with type 2 diabetes. Details: A small clinical study in patients with type 2 diabetes shows that substituting 26-52 grams of white wheat flour in bread with powdered, dehydrated apple and consuming the bread daily for up to 4 weeks does not improve fasting blood glucose or postprandial glucose levels when compared with a low-fiber white bread control (13141).
• Diarrhea. It is unclear if apple juice consumption is beneficial in infants with severe diarrhea. Details: A clinical study in infants with severe diarrhea shows that drinking apple juice 15 mL/kg twice daily during episodes of diarrhea results in more fecal loss when compared with drinking water (31687).
• Metabolic syndrome. Although there has been interest in using apple for metabolic syndrome, there is insufficient reliable information about the clinical effects of apple for this purpose.
• Muscle strength. Oral apple extract has only been evaluated in combination with other ingredients; its effects when used alone is unclear. Details: Small clinical studies in resistance trained males show that taking a specific blend of ancient peat and apple extract (elevATP, VDF FutureCeuticals Inc.) 150 mg daily as a liquid with liposomes (QuSomes, BioZone Laboratories Inc.) for 12 weeks modestly increases lower body and total strength, improves lower body power output, and increases cross-sectional area of muscle when compared with placebo (94418,94419).
• Obesity. It is unclear if apple consumption is beneficial in patients with overweight or obesity. Details: A small clinical study in females with hypercholesterolemia and overweight or obesity shows that eating apples three times daily for 12 weeks is associated with weight loss of 1.2 kg, compared with weight loss of 0.9 kg in those consuming oat cookies (17997). More evidence is needed to rate apple 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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LIKELY SAFE ...when used orally in food amounts. Eating apples and consuming apple juice is safe for most people. Apples are a common food source (3470,3472). However, eating apple seeds should be avoided because they can be toxic (6).

CHILDREN: LIKELY SAFE
when used orally in food amounts. Eating apples and consuming apple juice is safe for most people. Apples are a common food source (3470,3472).

CHILDREN: POSSIBLY SAFE
when apple pectin is used orally and appropriately, short-term. Preliminary clinical research suggests that combination products containing apple pectin and German chamomile (Diarrhoesan) are safe when used in infants for up to one week (19705,19706).

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of apple in amounts greater than those found in foods during pregnancy and lactation; avoid using.

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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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ALISKIREN (Tekturna, Rasilez) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of aliskiren.  Details Pharmacokinetic research shows that coadministration of apple juice 200 mL along with aliskiren 150 mg decreases the bioavailability of aliskiren by 63% (17670). Apple juice seems to inhibit organic anion transporting polypeptide (OATP), which is involved in drug uptake in the gut, liver, and kidney (7046,94413). It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, consuming apple juice with antidiabetes drugs might interfere with blood glucose control.  Details Clinical research suggests that consuming apples or drinking apple juice can raise blood glucose levels, with the effects of drinking apple juice being more significant than consuming apples (31699).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = B Consuming apple juice with antihypertensive drugs might interfere with blood pressure control.  Details Some clinical evidence suggests that consuming apple and cherry juice can increase blood pressure in elderly patients (31680).

ATENOLOL (Tenormin) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of atenolol.  Details Pharmacokinetic research shows that coadministration of apple juice 600-1200 mL decreases levels of atenolol by 58% to 82% in a dose-dependent manner (17999). Apple juice seems to inhibit organic anion transporting polypeptide (OATP), which is involved in drug uptake in the gut, liver, and kidney (7046). It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

FEXOFENADINE (Allegra) Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Likely •  Level of Evidence = B Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of fexofenadine.  Details Pharmacokinetic research shows that coadministration of apple juice 400-1200 mL along with fexofenadine 60-120 mg decreases bioavailability of fexofenadine by up to 78% (7046,94413). Coadministration with smaller quantities of apple juice (150 mL or less) does not appear to affect the bioavailability of fexofenadine (94421). Apple juice seems to inhibit organic anion transporting polypeptide (OATP), which is involved in drug uptake in the gut, liver, and kidney (7046,94413). It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D There is some concern that concomitant consumption of apple juice might decrease oral absorption and blood levels of lithium.  Details In one case report, a patient had an undetectable serum lithium level when lithium citrate was administered with apple juice. When lithium was administered with an alternative beverage, the lithium level became detectable and the patient demonstrated clinical improvement (105342).

ORGANIC ANION-TRANSPORTING POLYPEPTIDE SUBSTRATES (OATP) Interaction Rating = Major Do not take this combination. Severity = Moderate •  Occurrence = Likely •  Level of Evidence = B Concomitant consumption of apple juice can significantly decrease oral absorption and blood levels of OATP substrates.  Details Research shows that consuming apple juice inhibits OATP, which reduces bioavailability of oral drugs that are substrates of OATP (7046,17605). Fexofenadine, atenolol, and aliskiren are substrates of OATP. Clinical research shows that coadministration of apple juice decreases bioavailability of fexofenadine by up to 78% (7046,94413), aliskiren by 63% (17670), and atenolol by up to 82% (17999). These effects appear to increase with larger quantities of apple juice. It is thought that apple juice might affect OATP for only a short time. Therefore, separating drug administration and consumption of apple juice by at least 4 hours might avoid this interaction (17603,17604).

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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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General ...Orally, apple fruit is well tolerated. Apple seeds, which contain cyanide, may cause serious adverse effects when consumed in large amounts.
Most Common Adverse Effects:
Orally: Bloating, flatulence.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, including anaphylaxis. Ingestion of large amounts of apple seeds may cause cyanide poisoning, leading to death.

Gastrointestinal ...Orally, apple products, including whole apples, apple puree, and apple juice, may cause bloating and flatulence in some people (104184).

Immunologic ...Patients allergic to other fruits in the Rosaceae family, including apricot, almond, plum, peach, pear, and strawberry, can also be allergic to apples (7129). Rarely, the allergy has resulted in anaphylaxis (94425).

Other ...Orally, ingestion of large amounts of apple seeds, which contain hydrogen cyanide (HCN), may cause cyanide poisoning, leading to death. One death is attributed to ingestion of a cupful of apple seeds. To release cyanide, seeds must be hydrolyzed in the stomach, and several hours may elapse before poisoning symptoms occur (6).

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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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