Weight LossNCT02493140
Evaluation of Efficacy of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers
A study testing Cashew apple extract (Cashewin) in people with Weight Loss, run by Dialpha at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Cashew apple extract (Cashewin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinical Nutrition Center Naturalpha (CNCN)
Lille, 59020
CNCN, +33(0)320877575, cncn@naturalpha.com
Xavier Deplanque
About this study
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
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.
- Conditions
- Weight Loss
- Being tested
- Cashew apple extract (Cashewin), Placebo
- Keywords
- Weight management, cashew apple extract, overweight
- Medical subject headings
- Weight Loss, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDietary supplement
6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cashew apple extract (Cashewin) | Active comparator | Not described Receives: Dietary Supplement: Cashew apple extract (Cashewin) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight reduction
Measured: 12 weeks
Secondary outcomes (12)
Body weight variation
Measured: 6 weeks and 12 weeks
Body fat variation
Measured: 6 and 12 weeks
BMI variation
Measured: 6 and 12 weeks
Waist and hip circumferences variation
Measured: 6 and 12 weeks
Fasting glycemia variation
Measured: 12 weeks
Fasting insulinemia variation
Measured: 12 weeks
HOMA-IR index variation
Measured: 12 weeks
Variation of glycemia 2h post glucose solution intake
Measured: 12 weeks
Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation
Measured: 12 weeks
CRPus variation
Measured: 12 weeks
Systolic and diastolic blood pressure variation
Measured: 6 and 12 weeks
Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dialpha
- Sponsor type
- University, hospital or other
- Collaborators
- Naturalpha
- Responsible party
- Sponsor
- Investigators
- Xavier Deplanque, Principal investigator, Naturalpha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493140
- Sponsor's protocol ID
- 2015-A00160-49
- Status last verified
- Jul 2015
- First submitted
- 6 Jul 2015
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14985210Ribeiro 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.
PubMed 24054258Kuczmarski 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.
PubMed 11063431P. 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.
PubMed 23497120Vergara 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02493140
- Acronym / sponsor ID
- 2015-A00160-49
- Conditions
- Weight Loss
- Keywords
- Weight management, cashew apple extract, overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- DialphaUniversity, hospital or other
- Collaborators
- Naturalpha
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cashew apple extract (Cashewin) | Active comparator | Dietary Supplement: Cashew apple extract (Cashewin) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Cashew apple extract (Cashewin) |
| Placebo6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks | Dietary supplement | Placebo |
Primary outcome
Body weight reduction
Time frame: 12 weeks
12 secondary outcomes
Body weight variation
Time frame: 6 weeks and 12 weeks
Body fat variation
Time frame: 6 and 12 weeks
BMI variation
Time frame: 6 and 12 weeks
Waist and hip circumferences variation
Time frame: 6 and 12 weeks
Fasting glycemia variation
Time frame: 12 weeks
Fasting insulinemia variation
Time frame: 12 weeks
HOMA-IR index variation
Time frame: 12 weeks
Variation of glycemia 2h post glucose solution intake
Time frame: 12 weeks
Blood lipids (total cholesterol, HDL, LDL, triglycérides) variation
Time frame: 12 weeks
CRPus variation
Time frame: 12 weeks
Systolic and diastolic blood pressure variation
Time frame: 6 and 12 weeks
Safety (blood parameters measurements: urea, creatinine, ASAT, ALAT) with adverse events recording
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
- Background: PubMed 14985210Janssen 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.
- Background: PubMed 24054258Ribeiro 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.
- Background: PubMed 11063431Kuczmarski 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.
- BackgroundP. 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: PubMed 23497120Prasertsri 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.
- BackgroundVergara 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.
- Identification, Evaluation and Treatment of Overweight and Obesity in AdultsLink provided by the sponsor.
- Clinical guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in adultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Deplanque principal investigator
Naturalpha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cashew apple extract (Cashewin) in people with Weight Loss, run by Dialpha at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Peytavy-Izard (+33467404419, m.peytavy@dialpha.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight reduction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493140, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2015.