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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02493140
• Other study ID #: 2015-A00160-49
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2015
• Last updated: July 8, 2015
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: July 2015
• Source: Dialpha
• Contact: Marie Peytavy-Izard
• Phone: +33467404419
• Email: m.peytavy[@]dialpha.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
France	Clinical Nutrition Center Naturalpha (CNCN)	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Dialpha	Naturalpha

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. — View 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

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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight reduction		12 weeks	No
Secondary	Body weight variation		6 weeks and 12 weeks	No
Secondary	Body fat variation		6 and 12 weeks	No
Secondary	BMI variation		6 and 12 weeks	No
Secondary	Waist and hip circumferences variation		6 and 12 weeks	No
Secondary	Fasting glycemia variation		12 weeks	No
Secondary	Fasting insulinemia variation		12 weeks	No
Secondary	HOMA-IR index variation		12 weeks	No
Secondary	Variation of glycemia 2h post glucose solution intake		12 weeks	No
Secondary	Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation		12 weeks	No
Secondary	CRPus variation		12 weeks	No
Secondary	Systolic and diastolic blood pressure variation		6 and 12 weeks	Yes
Secondary	Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording		12 weeks	Yes

External Links

•   Clinical guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in adults
•   Guideline on clinical evaluation of medicinal products used in weight control (draft)
•   Identification, Evaluation and Treatment of Overweight and Obesity in Adults