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

July 8, 2015 updated by: Dialpha

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Recruiting
        • Clinical Nutrition Center Naturalpha (CNCN)
        • Contact:
        • Principal Investigator:
          • Xavier Deplanque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks
ACTIVE_COMPARATOR: Cashew apple extract (Cashewin)
Dietary supplement: Cashew apple extract (Cashewin)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight reduction
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight variation
Time Frame: 6 weeks and 12 weeks
6 weeks and 12 weeks
Body fat variation
Time Frame: 6 and 12 weeks
6 and 12 weeks
BMI variation
Time Frame: 6 and 12 weeks
6 and 12 weeks
Waist and hip circumferences variation
Time Frame: 6 and 12 weeks
6 and 12 weeks
Fasting glycemia variation
Time Frame: 12 weeks
12 weeks
Fasting insulinemia variation
Time Frame: 12 weeks
12 weeks
HOMA-IR index variation
Time Frame: 12 weeks
12 weeks
Variation of glycemia 2h post glucose solution intake
Time Frame: 12 weeks
12 weeks
Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation
Time Frame: 12 weeks
12 weeks
CRPus variation
Time Frame: 12 weeks
12 weeks
Systolic and diastolic blood pressure variation
Time Frame: 6 and 12 weeks
6 and 12 weeks
Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dialpha

Collaborators

Naturalpha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

February 1, 2016

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (ESTIMATE)

July 9, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 9, 2015

Last Update Submitted That Met QC Criteria

July 8, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00160-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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