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

NCT ID: NCT02493140

Last Updated: 2015-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

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.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cashew apple extract (Cashewin)

Group Type ACTIVE_COMPARATOR

Cashew apple extract (Cashewin)

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Naturalpha

INDUSTRY

Sponsor Role collaborator

Dialpha

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier Deplanque

Role: PRINCIPAL_INVESTIGATOR

Naturalpha

Locations

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Clinical Nutrition Center Naturalpha (CNCN)

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie Peytavy-Izard

Role: CONTACT

+33467404419

Facility Contacts

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CNCN

Role: primary

+33(0)320877575

References

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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.

Reference Type BACKGROUND
PMID: 14985210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24054258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11063431 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23497120 (View on PubMed)

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.

Reference Type BACKGROUND

Related Links

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

Identification, Evaluation and Treatment of Overweight and Obesity in Adults

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

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

Other Identifiers

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2015-A00160-49

Identifier Type: -

Identifier Source: org_study_id

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