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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Diabetes. It is unclear if oral Irvingia gabonensis is beneficial in patients with diabetes. Details: Preliminary clinical research shows that taking 4 grams of ground Irvingia gabonensis seed fiber orally, dissolved in 100 mL water, daily for one month can reduce fasting blood glucose, total cholesterol, and triglycerides, and can increase high-density lipoprotein (HDL) cholesterol, when compared with baseline in patients with type 2 diabetes (61589). The validity of these findings is limited by the lack of a comparator group.
• Hypercholesterolemia. It is unclear if oral Irvingia gabonensis is beneficial in patients with hypercholesterolemia. Details: Preliminary clinical research shows that taking Irvingia gabonensis crude seed extract 150 mg to 3.15 grams orally daily for 4-10 weeks lowers total and low-density lipoprotein (LDL) cholesterol and raises high-density lipoprotein (HDL) cholesterol in overweight adults who have normal or mildly elevated cholesterol levels when compared with placebo (17069,17070,104524). A meta-analysis of 5 small clinical studies in obese or overweight adults shows that taking Irvingia gabonensis 0.3-3.15 grams orally daily for 4-10 weeks reduces LDL by an average of 24% and increases HDL by an average of 10% when compared with placebo. The average change in triglycerides was inconclusive. However, the small size, poor quality, and heterogeneity of the included studies limits the validity of these findings (104524).
• Metabolic syndrome. It is unclear if oral Irvingia gabonensis is beneficial in patients with metabolic syndrome. Details: A preliminary clinical study in adults with metabolic syndrome shows that taking Irvingia gabonensis seed extract 150 mg orally twice daily for 90 days reduces triglycerides by 25%, waist circumference by 3%, and blood glucose upon oral glucose tolerance testing by 14%, but does not significantly affect low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, body weight, or body mass index, when compared with baseline. The validity of this study is limited by a very small sample size and the lack of a comparator group (104525).
• Obesity. Small clinical studies suggest that Irvingia gabonensis may modestly improves weight loss in overweight adults. Details: One preliminary clinical study shows that taking a crude seed extract 1.05 grams orally three times daily, combined with a low-fat, low-calorie diet, reduces weight by about 4 kg after 4 weeks, compared to no weight reduction in those taking placebo (17069). Another preliminary clinical study shows that taking a standardized seed extract (IGOB131) 150 mg twice daily orally for 10 weeks reduces weight by 12.8 kg, compared with 0.7 kg in those taking placebo. However, in this study, overweight patients taking Irvingia gabonensis consumed an average of 2767 kcal/day, compared to 3156 kcal/day in the placebo group (17070). Similar results also occurred in a study using a combination of standardized Irvingia gabonensis seed extract (IGOB131) and Cissus quadrangularis, for 10 weeks (16457). A meta-analysis of these and 2 additional trials in obese or overweight adults shows that taking Irvingia gabonensis 0.3-3.15 grams orally daily for 4-10 weeks reduces body weight by an average of 9%, body fat by 4%, and waist circumference by 7% when compared with placebo. However, the small size, poor quality, and heterogeneity of the included studies limits the validity of these findings (104524). In addition, some research shows conflicting results. Preliminary clinical research in overweight and obese individuals shows that taking a standardized seed extract (IGOB131) 300 mg orally daily for 12 weeks does not reduce body weight, body mass index, or fat mass when compared with placebo (112220). However, the study may have been inadequately powered to detect a difference between groups. The reasons for these discrepant findings are unclear but may be explained by differences in doses and patient populations studied or by changes in overall caloric intake, rather than the study drug. More evidence is needed to rate Irvingia gabonensis for these uses.

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POSSIBLY SAFE ...when Irvingia gabonensis seed extract is used orally and appropriately, short-term. Irvingia gabonensis crude seed extract has been used safely in doses of up to 1.05 grams three times daily for up to 12 weeks (17069,104524,104525). A standardized seed extract (IGOB131) has been used safely in doses up to 150 mg twice daily for up to 12 weeks (17070,112220).

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

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, taking Irvingia gabonensis with antidiabetes drugs might increase the risk of hypoglycemia in some patients.  Details Human research shows that Irvingia gabonensis decreases blood sugar in diabetic patients being treated with antidiabetes agents (61589,61591). Monitor blood glucose levels closely. Dose adjustments might be necessary.

TESTOSTERONE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking Irvingia gabonensis with testosterone products drugs might cause additive effects in some patients.  Details Animal research suggests that Irvingia gabonensis increases testosterone levels (61613). The mechanism of action is unclear. Until more is known, advise patients taking testosterone to avoid using or use Irvingia gabonensis cautiously.

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General ...Orally, Irvingia gabonensis is generally well tolerated.
Most Common Adverse Effects:
Orally: Flatulence, headache, insomnia, nausea.

Gastrointestinal ...Flatulence has been reported following 10 weeks of supplementation with Irvingia gabonensis alone (17070) or in combination with Cissus quadrangularis (16457). Similar events were observed in controls. Mild nausea has also been reported following the administration of Irvingia gabonensis 0.3-4 grams daily for up to 12 weeks; however, some of these symptoms were alleviated by the addition of milk to the test preparation (61589,112220).

Hepatic ...One case of acute hepatitis secondary to Irvingia gabonensis has been reported. A 45-year old male with a ten-day history of Irvingia gabonensis supplementation, at a dose of 350 mg of seed extract twice daily for body fat reduction, was admitted with jaundice, abdominal discomfort, and new onset malaise. His complaints began four days after starting Irvingia gabonensis supplementation. Prior to supplementation, all outpatient laboratory parameters were normal. At the time of admission, liver function tests were as follows: ALT 902 U/L, AST 708 U/L, alkaline phosphatase 198 U/L, gamma-glutamyl transferase 998 U/L, total bilirubin 9.1 mg/dL, direct bilirubin 6.1 mg/dL, and serum albumin 4.2 grams/dL. Hemoglobin was 15.3 grams/dL, white blood cell count 9.2 x 10³ /mm³, platelets 240 x 10³/mm³, prothrombin time 16.1 seconds, and ferritin level 115 ng/mL. Urinalysis revealed 2+ bilirubin and urobilinogens. Tests for viral hepatitis, autoimmune hepatitis, hemochromatosis, alpha-1-antitypsin deficiency, and Wilson's disease were negative. Ultrasonography showed a bright liver parenchyma consistent with steatosis, 15 cm in vertical size with regular edges. A spleen 13 cm in vertical size was also seen. Acute hepatitis secondary to Irvingia gabonensis was the diagnosis. When the Irvingia gabonensis capsules were discontinued, an immediate improvement was seen. Liver enzymes and other laboratory tests were normal 3 weeks after the admission (92824).

Neurologic/CNS ...Headache and insomnia have been reported in patients taking Irvingia gabonensis alone or in conjunction with Cissus quadrangularis for periods of 10 weeks (16457,17070). Similar events were observed in control groups.

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