Status:
COMPLETED
Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers
Lead Sponsor:
Kitozyme
Collaborating Sponsors:
Naturalpha
Conditions:
Overweight and Obese Volunteers.
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The prevalence of overweight and obesity is getting more and more important in developed as well as in emerging countries. It can be defined according to the degree of fat storage by measurement of fa...
Detailed Description
The study duration per subject will be 3 months and 1 week maximum. Subjects will be screened at visit V1 and will start a 1-week run-in period, during which subjects will ingest 2 capsules of placebo...
Eligibility Criteria
Inclusion
- Males and females volunteers, able to read and write.
- Subject with 25 ≤ Body Mass Index ≤ 35 kg/m².
- Subject with a good physical condition based on the subject's interview and the clinical exam performed by the Investigator.
- Subject with stable body weight (\< 5% variation) within the last 3 months prior to screening (based on interview).
- Written informed consent provided prior to screening, after receiving and understanding the subject information.
- Subject willing to lose weight.
- Subject accepting to follow diet and lifestyle instructions throughout the study.
- Subject willing to take study capsules three times a day for 3 months and 1 week and undergo other study-related procedures.
- Registered with the French Social Security, in agreement with the French law on biomedical experimentation.
Exclusion
- Smoker or former smoker having stopped within 2 months prior to screening visit.
- Subject with a history of alcohol or drug abuse.
- Subject with physical activity more than 3 hours per week.
- Subject with any sensitivity or allergy to any of the products used within this clinical trial.
- Subject with history of eating disorder (anorexia nervosa, bulimia nervosa).
- Subject having used weight reduction treatments or products during the last 3 months prior to screening visit.
- Subject with significant gastrointestinal disease (e.g. coeliac disease, pancreatitis), signs of intestinal obstruction or medical history of constipation.
- Intake of chronic medication which could interfere with study parameters (weight, appetite, satiety, lipid blood levels, glycemia, gastrointestinal function), having an effect on digestion or absorption of nutrients, excepted oestroprogestative or progestative contraception started at least three months before the screening visit.
- Female subject planning a pregnancy, pregnant or breastfeeding.
- Female subject without efficient contraceptive method.
- Subject with history of bariatric surgery.
- Subject with known systemic disease such as cancer, human immunodeficiency virus (HIV) seropositivity.
- Subject with type 1 or type 2 diabetes mellitus.
- Subject with history of significant medical or surgical event requiring hospitalization during the 3 months prior the screening visit.
- Subject having, had or scheduling to have an exam that uses barium, a radioisotope injection, or oral or intravenous contrast material within 2 weeks prior screening visit and during the study.
- Participation to any other clinical trial simultaneously and/or within 1 month prior the screening visit.
- Subject who has donated blood or blood products within the previous month prior to screening or who plans to donate blood or blood products at any time during the trial and in the 3 months following the end of the study.
- Subject judged unlikely to comply with study product intake (screening compliance \< 80%) and with diet and lifestyle instructions.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT02246699
Start Date
September 1 2014
End Date
March 1 2015
Last Update
March 31 2015
Active Locations (1)
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1
Clinical Nutrition Center Naturalpha (CNCN)
Lille, France, 59120