Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers
NCT ID: NCT02246699
Last Updated: 2015-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2014-09-30
2015-03-31
Brief Summary
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No clinical studies have been conducted so far for that intended use on KiOnutrime®-Cs, a fungal chitosan from the mycelium of non-genetically modified Aspergillus niger. KiOnutrime®-Cs has been recognized as substantially equivalent to animal chitosan.
The purpose of this clinical trial is to determine if KiOnutrime®-Cs-containing medical device, which is a CE-marked medical device manufactured by KitoZyme, has an effect on body weight reduction after 3 months of intake in overweight and obese men and women. Furthermore, effects on anthropometric measurements, body fat mass percentage, serum lipids and safety parameters will be investigated.
Detailed Description
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The subjects will then be randomized to receive the investigational medical device or placebo (1:1) for a 3 months product intake period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KiOnutrime®-Cs
The product is presented as a capsule containing chitosan as ingredient supporting the activity.
KiOnutrime®-Cs
The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules of 500mg, 3 times per day.
Placebo
Placebo is presented as a capsule containing inactive ingredients.
Placebo
The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules, 3 times per day.
Interventions
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KiOnutrime®-Cs
The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules of 500mg, 3 times per day.
Placebo
The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules, 3 times per day.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Naturalpha
INDUSTRY
Kitozyme
INDUSTRY
Responsible Party
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Principal Investigators
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Audrey DESCHAMPS, PhD
Role: STUDY_DIRECTOR
Kitozyme, Belgium
Xavier DEPLANQUE, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Nutrition Center Naturalpha, France
Locations
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Clinical Nutrition Center Naturalpha (CNCN)
Lille, , France
Countries
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Other Identifiers
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ID-RCB Number : 2014-A01026-41
Identifier Type: OTHER
Identifier Source: secondary_id
14-041
Identifier Type: -
Identifier Source: org_study_id