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

• 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

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
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
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
BMI variation	6 and 12 weeks
CRPus variation	12 weeks

Trial Locations

Locations (1)

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