Evaluation of Efficacy of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Efficacy and Safety of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers: a Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Cashew apple extract (Cashewin)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cashew apple extract (Cashewin)<br> | Dietary Supplement: Cashew apple extract (Cashewin)<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight reduction |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight variation |  | 6 weeks and 12 weeks | 
| 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 | 
| HOMA-IR index variation |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight management, cashew apple extract, overweight