Weight Loss
Conditions
Keywords
Weight management, cashew apple extract, overweight
Brief summary
The purpose of this study is to assess the efficacy and safety of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers, versus placebo, after 12 weeks of treatment.
Interventions
6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner, each capsule containing 200 mg of Cashewin) during 12 weeks
6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks
Sponsors
Study design
Eligibility
Inclusion criteria
* 27 ≤ BMI ≤ 35 kg/m² * Abdominal obesity * Acceptance to adhere to diet and physical activity recommendations while maintaining global lifestyle habits * Stable body weight (\<5% variation) within the last 3 months prior to screening
Exclusion criteria
* Allergy to nuts and products thereof and allergy to mango fruit * Type I or II diabetes * Smokers * Severe chronic diseases * History of bariatric surgery and eating disorders * Use of weight management products or medications which could affect nutrients absorption, lipids or carbohydrates metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight reduction | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Body fat variation | 6 and 12 weeks |
| BMI variation | 6 and 12 weeks |
| Waist and hip circumferences variation | 6 and 12 weeks |
| Fasting glycemia variation | 12 weeks |
| Fasting insulinemia variation | 12 weeks |
| Body weight variation | 6 weeks and 12 weeks |
| Variation of glycemia 2h post glucose solution intake | 12 weeks |
| Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation | 12 weeks |
| CRPus variation | 12 weeks |
| Systolic and diastolic blood pressure variation | 6 and 12 weeks |
| Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording | 12 weeks |
| HOMA-IR index variation | 12 weeks |
Countries
France