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

Primary Purpose

Weight Loss

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cashew apple extract (Cashewin)

Placebo

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring Weight management, cashew apple extract, overweight

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Nutrition Center Naturalpha (CNCN)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cashew apple extract (Cashewin)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Body weight reduction

Secondary Outcome Measures

Body weight variation

Body fat variation

BMI variation

Waist and hip circumferences variation

Fasting glycemia variation

Fasting insulinemia variation

HOMA-IR index variation

Variation of glycemia 2h post glucose solution intake

Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation

CRPus variation

Systolic and diastolic blood pressure variation

Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording

Full Information

NCT ID

NCT02493140

First Posted

July 6, 2015

Last Updated

July 8, 2015

Sponsor

Dialpha

Collaborators

Naturalpha

1. Study Identification

Unique Protocol Identification Number

NCT02493140

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dialpha

Collaborators

Naturalpha

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss

Keywords

Weight management, cashew apple extract, overweight

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cashew apple extract (Cashewin)

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Cashew apple extract (Cashewin)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks

Primary Outcome Measure Information:

Title

Body weight reduction

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Body weight variation

Time Frame

6 weeks and 12 weeks

Title

Body fat variation

Time Frame

6 and 12 weeks

Title

BMI variation

Time Frame

6 and 12 weeks

Title

Waist and hip circumferences variation

Time Frame

6 and 12 weeks

Title

Fasting glycemia variation

Time Frame

12 weeks

Title

Fasting insulinemia variation

Time Frame

12 weeks

Title

HOMA-IR index variation

Time Frame

12 weeks

Title

Variation of glycemia 2h post glucose solution intake

Time Frame

12 weeks

Title

Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation

Time Frame

12 weeks

Title

CRPus variation

Time Frame

12 weeks

Title

Systolic and diastolic blood pressure variation

Time Frame

6 and 12 weeks

Title

Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie Peytavy-Izard

Phone

+33467404419

m.peytavy@dialpha.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xavier Deplanque

Organizational Affiliation

Naturalpha

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Nutrition Center Naturalpha (CNCN)

City

Lille

ZIP/Postal Code

59020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

CNCN

Phone

+33(0)320877575

cncn@naturalpha.com

First Name & Middle Initial & Last Name & Degree

Xavier Deplanque

12. IPD Sharing Statement

Citations:

PubMed Identifier

14985210

Citation

Janssen I, Katzmarzyk PT, Ross R. Waist circumference and not body mass index explains obesity-related health risk. Am J Clin Nutr. 2004 Mar;79(3):379-84. doi: 10.1093/ajcn/79.3.379.

Results Reference

background

PubMed Identifier

24054258

Citation

Ribeiro da Silva LM, Teixeira de Figueiredo EA, Silva Ricardo NM, Pinto Vieira IG, Wilane de Figueiredo R, Brasil IM, Gomes CL. Quantification of bioactive compounds in pulps and by-products of tropical fruits from Brazil. Food Chem. 2014 Jan 15;143:398-404. doi: 10.1016/j.foodchem.2013.08.001. Epub 2013 Aug 9.

Results Reference

background

PubMed Identifier

11063431

Citation

Kuczmarski RJ, Flegal KM. Criteria for definition of overweight in transition: background and recommendations for the United States. Am J Clin Nutr. 2000 Nov;72(5):1074-81. doi: 10.1093/ajcn/72.5.1074.

Results Reference

background

Citation

P. Suganya and R. Dharshini. Value added products from cashew apple - an alternate nutritional source. International Journal of current research, Vol. 3, Issue 7, pp. 177-180, July 2011

Results Reference

background

PubMed Identifier

23497120

Citation

Prasertsri P, Roengrit T, Kanpetta Y, Tong-Un T, Muchimapura S, Wattanathorn J, Leelayuwat N. Cashew apple juice supplementation enhanced fat utilization during high-intensity exercise in trained and untrained men. J Int Soc Sports Nutr. 2013 Mar 7;10(1):13. doi: 10.1186/1550-2783-10-13.

Results Reference

background

Citation

Vergara CMAC, Honorato TL, Maia GA, Rodrigues S. Prebiotic effect of fermented cashew apple (Anacardium occidentale L) juice. LWT-Food Sci Technol. 2010; 43:141-145.

Results Reference

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Links:

URL

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/07/WC500170278.pdf

Description

Guideline on clinical evaluation of medicinal products used in weight control (draft)

URL

http://www.nhlbi.nih.gov/files/docs/guidelines/prctgd_c.pdf

Description

Identification, Evaluation and Treatment of Overweight and Obesity in Adults

URL

http://www.nhlbi.nih.gov/files/docs/guidelines/ob_gdlns.pdf

Description

Clinical guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in adults

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

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