Clinical trial NCT02493140: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Keywords: Weight management
cashew apple extract
overweight
Lead sponsor: Dialpha
Sponsor class: OTHER
Collaborators: name: Naturalpha
First posted: 2015-07-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Body weight reduction
timeFrame: 12 weeks
Secondary outcomes:
measure: Body weight variation
timeFrame: 6 weeks and 12 weeks
measure: Body fat variation
timeFrame: 6 and 12 weeks
measure: BMI variation
timeFrame: 6 and 12 weeks
measure: Waist and hip circumferences variation
timeFrame: 6 and 12 weeks
measure: Fasting glycemia variation
timeFrame: 12 weeks
measure: Fasting insulinemia variation
timeFrame: 12 weeks
measure: HOMA-IR index variation
timeFrame: 12 weeks
measure: Variation of glycemia 2h post glucose solution intake
timeFrame: 12 weeks
measure: Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation
timeFrame: 12 weeks
measure: CRPus variation
timeFrame: 12 weeks
measure: Systolic and diastolic blood pressure variation
timeFrame: 6 and 12 weeks
measure: Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinical Nutrition Center Naturalpha (CNCN)
Study officials:
affiliation: Naturalpha
name: Xavier Deplanque
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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
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.
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.