NCT02493140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 9, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

July 6, 2015

Last Update Submit

July 8, 2015

Conditions

Weight Loss

Keywords

Weight managementcashew apple extractoverweight

Outcome Measures

Primary Outcomes (1)

  • Body weight reduction

    12 weeks

Secondary Outcomes (12)

  • Body weight variation

    6 weeks and 12 weeks

  • Body fat variation

    6 and 12 weeks

  • BMI variation

    6 and 12 weeks

  • Waist and hip circumferences variation

    6 and 12 weeks

  • Fasting glycemia variation

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Cashew apple extract (Cashewin)

ACTIVE COMPARATOR
Dietary Supplement: Cashew apple extract (Cashewin)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

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

Cashew apple extract (Cashewin)
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≤ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Center Naturalpha (CNCN)

Lille, 59020, France

RECRUITING

Related 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. doi: 10.1093/ajcn/79.3.379.

    PMID: 14985210BACKGROUND

  • 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.

    PMID: 24054258BACKGROUND

  • 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.

    PMID: 11063431BACKGROUND

  • 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

    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.

    PMID: 23497120BACKGROUND

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Weight LossOverweight

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Xavier Deplanque

    Naturalpha

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Peytavy-Izard

CONTACT

+33467404419m.peytavy@dialpha.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 9, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

July 9, 2015

Record last verified: 2015-07

Locations

FR(1)