Clinical trial NCT02246699: Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers
Official title: A Study to Evaluate the Efficacy and the Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers: a Randomized, Double-blind, Parallel Groups and Placebo Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obese Volunteers.
Keywords: obesity
overweight
chitosan
fungal chitosan
weight management
Lead sponsor: Kitozyme
Sponsor class: INDUSTRY
Collaborators: name: Naturalpha
First posted: 2014-09-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 fat mass.

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: 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 3 times a day.

The subjects will then be randomized to receive the investigational medical device or placebo (1:1) for a 3 months product intake period.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Body weight
timeFrame: 0 ; 30 ; 60 ; 90 days
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: 0 ; 30 ; 60 ; 90 days
measure: Body fat mass
timeFrame: 0 - 90 days
measure: Hunger and satiety sensation
timeFrame: -7 ; 0 ; 30 ; 60 ; 90 days
measure: Serum lipids
timeFrame: 0 - 90 days
measure: Blood pressure
timeFrame: 0 ; 30 ; 60 ; 90 days
measure: Electrolytic measurements and fat-soluble vitamins
timeFrame: 0 - 90 days
measure: Gastrointestinal tolerance
timeFrame: -7 ; 0 ; 30 ; 60 ; 90 days
measure: Safety blood parameters
timeFrame: 0 - 90 days
measure: Adverse events
timeFrame: Study duration
measure: Physical Activity score
timeFrame: -7 ; 0 ; 30 ; 60 ; 90 days
measure: Food recording
timeFrame: 0 ; 30 ; 60 ; 90 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Clinical Nutrition Center Naturalpha (CNCN)
Study officials:
affiliation: Kitozyme, Belgium
name: Audrey DESCHAMPS, PhD
role: STUDY_DIRECTOR
affiliation: Clinical Nutrition Center Naturalpha, France
name: Xavier DEPLANQUE, MD
role: PRINCIPAL_INVESTIGATOR
References: