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

Not Applicable

• Conditions: Weight Loss
• Interventions: Dietary Supplement: Cashew apple extract (Cashewin); Dietary Supplement: Placebo

• Registration Number: NCT02493140
• Lead Sponsor: Dialpha

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-07
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Study First Posted: 2015-07-09
• Last Update Posted: 2015-07-09
• Primary Completion: 2015-12
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cashew apple extract (Cashewin)	Cashew apple extract (Cashewin)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Body weight reduction	12 weeks

Secondary Outcome Measures

Name	Time	Method
Waist and hip circumferences variation	6 and 12 weeks
Fasting glycemia variation	12 weeks
BMI variation	6 and 12 weeks
Fasting insulinemia variation	12 weeks
HOMA-IR index variation	12 weeks
Body weight variation	6 weeks and 12 weeks
Body fat variation	6 and 12 weeks
Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation	12 weeks
CRPus variation	12 weeks
Variation of glycemia 2h post glucose solution intake	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

Trial Locations

Locations (1)

Clinical Nutrition Center Naturalpha (CNCN); 🇫🇷 Lille, France