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| Name | Class |
|---|---|
| Naturalpha | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cashew apple extract (Cashewin) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cashew apple extract (Cashewin) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight reduction | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight variation | 6 weeks and 12 weeks | |
| Body fat variation | 6 and 12 weeks | |
| BMI variation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Peytavy-Izard | Contact | +33467404419 | m.peytavy@dialpha.com |
| Name | Affiliation | Role |
|---|---|---|
| Xavier Deplanque | Naturalpha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Center Naturalpha (CNCN) | Recruiting | Lille | 59020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14985210 | Background | 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. | |
| 24054258 | Background | 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. |
| Label | URL |
|---|---|
| Identification, Evaluation and Treatment of Overweight and Obesity in Adults | View source |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | 6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks |
|
| 6 and 12 weeks |
| Waist and hip circumferences variation | 6 and 12 weeks |
| Fasting glycemia variation | 12 weeks |
| Fasting insulinemia variation | 12 weeks |
| HOMA-IR index variation | 12 weeks |
| Variation of glycemia 2h post glucose solution intake | 12 weeks |
| Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation | 12 weeks |
| CRPus variation | 12 weeks |
| Systolic and diastolic blood pressure variation | 6 and 12 weeks |
| Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording | 12 weeks |
| 11063431 | Background | 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. |
| Background | 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 |
| 23497120 | 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. |
| Background | 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. |
| Clinical guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in adults | View source |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |