Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers

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.

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obese Volunteers.
• Intervention / Treatment: Device: KiOnutrime®-Cs; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59120
    • Clinical Nutrition Center Naturalpha (CNCN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KiOnutrime®-Cs; The product is presented as a capsule containing chitosan as ingredient supporting the activity.	Device: 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 Comparator: Placebo; Placebo is presented as a capsule containing inactive ingredients.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Comparison of the reduction of body weight, from baseline (randomization visit) to end-point (3 months of treatment), between KiOnutrime®-Cs and placebo arms.	0 ; 30 ; 60 ; 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurements	Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in anthropometric measurements (Body Mass Index, waist, hip and thigh circumferences) between KiOnutrime®-Cs and placebo.	0 ; 30 ; 60 ; 90 days
Body fat mass	Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in body fat mass percentage (fat mass, bone mass and lean mass measured by Dual-energy X-ray absorptiometry) between KiOnutrime®-Cs and placebo.	0 - 90 days
Hunger and satiety sensation	Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in hunger and satiety sensation via Visual Analog Scales measures between KiOnutrime®-Cs and placebo.	-7 ; 0 ; 30 ; 60 ; 90 days
Serum lipids	Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in serum lipids (triglycerides and cholesterol) between KiOnutrime®-Cs and placebo.	0 - 90 days
Blood pressure	Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in systolic and diastolic blood pressure between KiOnutrime®-Cs and placebo.	0 ; 30 ; 60 ; 90 days
Electrolytic measurements and fat-soluble vitamins	Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in electrolytic measurements (Calcium, Magnesium, Sodium, Potassium) and fat-soluble vitamins (A, D, E) in plasma between KiOnutrime®-Cs and placebo.	0 - 90 days
Gastrointestinal tolerance	Evaluation of the gastrointestinal tolerance of KiOnutrime®-Cs with a questionnaire at baseline (randomization visit), 30 days, 60 days and 90 days compared to placebo.	-7 ; 0 ; 30 ; 60 ; 90 days
Safety blood parameters	Evaluation of the safety of KiOnutrime®-Cs through safety blood parameters measurements (urea, creatinine, glucose, Aspartate Aminotransferase and Alanine Aminotransferase).	0 - 90 days
Adverse events	Evaluation of the safety of KiOnutrime®-Cs through adverse events recording.	Study duration
Physical Activity score	Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in Physical Activity score (via Physical activity questionnaire).	-7 ; 0 ; 30 ; 60 ; 90 days
Food recording	Estimation of total intake of food energy (calories), nutrients, and non-nutrient food components from foods and beverages that were consumed during a 3 days period prior to study visits from randomization to last visit.	0 ; 30 ; 60 ; 90 days

Collaborators and Investigators

• Sponsor: Kitozyme
• Collaborators: Naturalpha
• Investigators: Principal Investigator: Xavier DEPLANQUE, MD, Clinical Nutrition Center Naturalpha, France; Study Director: Audrey DESCHAMPS, PhD, Kitozyme, Belgium

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 19, 2014
• First Submitted That Met QC Criteria: September 19, 2014
• First Posted (Estimate): September 23, 2014

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: obesity; overweight; weight management; chitosan; fungal chitosan
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight Changes; Obesity; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: 14-041; ID-RCB Number : 2014-A01026-41 (Other Identifier: ANSM)