Buddy Bear Fiber Natural Very Cherry Flavor by Renew Life

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dental plaque. It is unclear if oral or topical gum arabic is beneficial for preventing or treating dental plaque. Details: Preliminary clinical research shows that chewing gum arabic for 10 minutes, five times daily for 7 days, reduces dental plaque when compared with chewing sugar-free gum (30220). Another small clinical study in adults with mild or moderate plaque-induced gingivitis shows that applying half a teaspoon of gum arabic powder to the buccal surface of dentogingivial areas for 5 minutes then rinsing with tap water twice daily for 60 days reduces dental plaque in patients with moderate, but not high, plaque accumulation when compared with placebo (111508). Gum arabic has also been evaluated in combination with other ingredients for this purpose. A small clinical study shows that applying a pea-size amount of gel containing gum arabic, barleria, medlar, terminalia, and melia (Gum Tone Gel, Charak Pharma Pvt Ltd.) after brushing for 6 weeks decreases plaque severity when compared with placebo. The gel is similar in effectiveness to chlorhexidine 1% gel (92887). However, it's unclear if these findings are due to gum arabic, other ingredients, or the combination.
• Diabetes. It is unclear if oral gum arabic is beneficial in patients with diabetes. Details: Clinical research in adults with type 2 diabetes who are taking oral antidiabetes medications shows that taking gum arabic powder 30 grams daily in the morning for 3 months modestly reduces fasting blood glucose and glycated hemoglobin (HbA1c) when compared with baseline. Gum arabic also modestly reduces low-density lipoprotein (LDL) cholesterol levels, body mass index, and hip circumference, but not waist circumference or blood pressure, when compared with baseline (98700,99098). The validity of these findings is limited by the lack of a comparison to the placebo group.
• Gingivitis. It is unclear if topical gum arabic is beneficial in patients with gingivitis. Details: A small clinical study in adults with mild or moderate plaque-induced gingivitis shows that applying half a teaspoon of gum arabic powder to the buccal surface of dentogingivial areas for 5 minutes then rinsing with tap water twice daily for 60 days reduces gingival inflammation in patients with mild, but not moderate, gingivitis when compared with placebo (111508). Another small clinical study in patients with chronic gingivitis shows that applying a pea-size amount of gel containing a mixture of ingredients including gum arabic, barleria, medlar, terminalia, and melia (Gum Tone Gel, Charak Pharma Pvt Ltd.) after brushing for 6 weeks decreases gingivitis severity when compared with placebo. The gel was no better than using chlorhexidine 1% gel (92887). However, it's unclear if these findings are due to gum arabic, other ingredients, or the combination.
• Hypercholesterolemia. It is unclear if oral gum arabic helps to reduce high cholesterol levels. Details: One small clinical study in patients with hypercholesterolemia shows that taking gum arabic 5 grams twice daily for 4 weeks does not seem to affect plasma lipid levels when compared with baseline (8072).
• Irritable bowel syndrome (IBS). Although there is interest in using oral gum arabic for IBS, there is insufficient reliable information about the clinical effects of gum arabic for this condition.
• Kidney failure. Although there is interest in using oral gum arabic for kidney failure, there is insufficient reliable information about the clinical effects of gum arabic for this condition.
• Metabolic syndrome. It is unclear if oral gum arabic is beneficial for preventing metabolic syndrome. Details: One small clinical study in healthy adults at risk for metabolic syndrome shows that taking gum arabic 20 grams daily for 12 weeks modestly reduces blood pressure and increases fat-free mass when compared with baseline, but not when compared with taking pectin 1 gram. There were no changes in weight, glycated hemoglobin, or cholesterol levels (105039).
• Obesity. It is unclear if oral gum arabic is beneficial for promoting weight loss. Details: One small clinical study in healthy adults shows that taking powdered gum arabic 18 grams in the morning and 12 grams in the evening for 6 weeks reduces body mass index by 0.32 kg/m2 and body fat percentage by about 2% when compared with placebo. Body weight was also reduced by 1.2%, but this was not significant when compared with placebo (18237). It is unclear if gum arabic is beneficial in individuals with obesity.
• Peristomal lesions. It is unclear if topical gum arabic is beneficial for preventing peristomal lesions in patients with a colostomy bag. Details: Preliminary clinical research in infants shows that applying a thick layer of gum arabic gel to peristomal skin before attaching a colostomy bag twice daily for 4 weeks decreases the incidence of postoperative peristomal dermatitis by about 78% when compared with zinc sulfate ointment (92886).
• Sickle cell disease. It is unclear if oral gum arabic is beneficial in patients with sickle cell disease. Details: Preliminary clinical research in patients with sickle cell disease shows that taking gum arabic powder 30 grams daily for 12 weeks does not improve most markers of liver and kidney function in these patients. While an improvement in direct bilirubin levels was observed when compared to baseline, no significant changes in serum levels of total bilirubin, albumin, protein, liver enzymes, urea, or creatinine were reported (102087). However, in this same group of patients, gum arabic did reduce levels of total cholesterol by 8 mg/dL, low-density lipoprotein (LDL) cholesterol by 5 mg/dL, and triglycerides by 12 mg/dL when compared with baseline. Significant improvements in high-density lipoprotein (HDL) cholesterol were lacking (102088). This research is limited by the lack of a control group, Also, it is unclear whether gum arabic can improve clinical outcomes in patients with sickle cell disease. More evidence is needed to rate the effectiveness of gum arabic for these uses.

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. It is unclear if oral stevia is beneficial in patients with diabetes; the available research is conflicting. Details: A small single-dose study shows that taking stevia leaf extract 1000 mg, standardized to contain 91% stevioside, along with a meal reduces postprandial glucose levels by 18% in adults with type 2 diabetes when compared with a starch control (11812). However, clinical research in patients with type 1 or type 2 diabetes shows that taking stevioside 250 mg three times daily for 3 months does not affect blood glucose levels or glycated hemoglobin (HbA1C) when compared with baseline (16705). Also, a small clinical study in patients with diabetes shows that drinking 200 mL of black tea, sweetened with stevia extract 2%, three times daily for 8 weeks does not affect glycemic indices when compared with drinking tea sweetened with sucralose (103695).
• Hypertension. It is unclear if oral stevia is beneficial in patients with hypertension; the available research is conflicting. Details: Some clinical research in patients with mild to moderate hypertension shows that taking stevioside, a constituent of stevia, 750-1500 mg in three divided doses daily reduces systolic blood pressure by 10-14 mmHg and diastolic blood pressure by 6-14 mmHg within one week to three months of treatment initiation and continuing for up to 2 years (11809,11810). However, other clinical research in patients with mild hypertension shows that taking stevioside in doses up to 15 mg/kg daily does not significantly reduce blood pressure (16706).
• Obesity. It is unclear if oral stevia is beneficial in patients with obesity; the available research is conflicting. Details: Although a small clinical study in healthy adults shows that drinking water with stevia (Truvia) 245 ppm as a single dose reduces appetite and energy intake when compared with drinking water alone (103697), other small, single-dose studies have shown no effect of stevia 15.3 mg or 1 gram as a single dose on satiety, energy intake, or fullness when compared with either water alone or a non-nutritive sweetener (103696,110124). A small clinical study in healthy adults shows that taking an aqueous stevia leaf extract (SweetLeaf) twice daily for 12 weeks does not affect body weight, compared with an increase in weight in the control group. This suggests that stevia extract may have attenuated weight gain in this study (106458). More evidence is needed to rate stevia for these uses.

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LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. Gum arabic has Generally Recognized As Safe (GRAS) status for use in foods in the US. It is also considered to be safe for use as a food additive by the European Food Safety Authority (4912,105040).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts (8072). Up to 30 grams daily of powdered gum arabic has been used with apparent safety for 3 months (18237,99098,105040).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using in amounts greater than those found in foods (4912,105040).

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LIKELY SAFE ...when certain stevia constituents, including stevioside and rebaudiosides A, D, and M, are used orally as sweeteners in foods. These constituents have generally recognized as safe (GRAS) status in the US for this purpose (16699,16700,16702,16705,16706,108049). The stevia constituent stevioside has been safely used in doses of up to 1500 mg daily for 2 years (11809,11810,11811). There is insufficient reliable information available about the safety of whole stevia or stevia extracts when used orally. The European Food Safety Authority (EFSA) has determined that the acceptable intake of steviol glycosides is 4 mg/kg daily (106456); however, it is unclear how this relates to the use of whole stevia or stevia extract.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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AMOXICILLIN (Amoxil, Trimox) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Gum arabic can reduce the absorption of amoxicillin.  Details A small study in healthy volunteers shows that taking amoxicillin and gum arabic concurrently significantly reduces the absorption of amoxicillin. Separate doses of amoxicillin from gum arabic by at least 2 hours (12654).

ORAL DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, gum arabic can alter the absorption of oral drugs due to its fiber content.  Details Gum arabic has been used as a suspending osmotic agent in drug formulations. It might improve bioavailability of water-insoluble drugs like naproxen, but reduce absorption of polar drugs like amoxicillin (12654,104058). To avoid changes in absorption, take gum arabic 30-60 minutes after oral medications.

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ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, stevia might increase the risk for hypoglycemia when combined with antidiabetes drugs.  Details Preliminary clinical research in patients with type 2 diabetes suggests that taking a single dose of stevia extract 1000 mg reduces postprandial blood glucose levels when taken with a meal (11812). However, other clinical research in patients with type 1 or type 2 diabetes suggests that taking stevioside 250 mg three times daily does not significantly affect blood glucose levels or glycated hemoglobin (HbA1C) after three months of treatment (16705).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, combining stevia or stevia constituents with antihypertensive agents might increase the risk of hypotension.  Details Stevia extract and stevioside might lower blood pressure in patients with hypertension (3745,3747,5031,11809,11810). However, other clinical research suggests that stevioside does not significantly lower blood pressure in patients with hypertension (16706).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, stevia might decrease clearance and increase levels of lithium.  Details Animal research suggests that stevia extracts might have diuretic activity (3746,3747). Theoretically, increased reabsorption of lithium along with sodium might reduce excretion and increase levels of lithium.

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General ...Orally, gum arabic seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Abdominal bloating, flatulence, mild diarrhea, nausea, and vomiting.

Gastrointestinal ...Orally, gum arabic can cause minor gastrointestinal disturbances such as abdominal bloating, flatulence, nausea, vomiting, cramping, and mild diarrhea (8072,18237,99098,105038,105040,108051). These effects occurred in 15%, 82%, and 90% of subjects respectively in one study (18237). They may subside with continued use within 2 weeks (8072,18237,99098,105038).

Immunologic ...Gum arabic might cause allergic reactions. In one case report, a patient had an immunoglobulin E response after exposure to gum arabic. However, there have been no identified case reports of allergic reactions after oral exposure to gum arabic (19636,105040).

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General ...Orally, stevia and steviol glycosides appear to be well tolerated. Most minor adverse effects seem to resolve after the first week of use.
Most Common Adverse Effects:
Abdominal bloating, dizziness, headache, myalgia, nausea, and numbness.
Serious Adverse Effects (Rare):
Allergic reactions.

Gastrointestinal ...Orally, stevia and steviol glycosides such as stevioside, can cause gastrointestinal adverse effects such as abdominal fullness and nausea. However, these generally resolve after the first week of use (11809,11810).

Immunologic ...Theoretically, stevia might cause allergic reactions in individuals sensitive to plants in the Asteraceae/Compositae family (11811). Members of this family include ragweed, chrysanthemums, marigolds, daisies, and many other herbs.

Musculoskeletal ...Orally, stevia and steviol glycosides may cause myalgia, but this generally resolves after the first week of use (11809,11810).

Neurologic/CNS ...Orally, stevia and steviol glycosides may cause headache, dizziness, and numbness (11809,11810).

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