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

NCT02246699 | Completed

• 2 other identifiers: 14-041ID-RCB Number : 2014-A01026-41
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obese Volunteers.

Keywords

obesity; overweight; chitosan; fungal chitosan; weight management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Anthropometric measurements

  0 ; 30 ; 60 ; 90 days

• Body fat mass

  0 - 90 days

• Hunger and satiety sensation

  -7 ; 0 ; 30 ; 60 ; 90 days

• Serum lipids

  0 - 90 days

• Blood pressure

  0 ; 30 ; 60 ; 90 days

Study Arms (2)

KiOnutrime®-Cs

EXPERIMENTAL

The product is presented as a capsule containing chitosan as ingredient supporting the activity.

Device: KiOnutrime®-Cs

Placebo

PLACEBO COMPARATOR

Placebo is presented as a capsule containing inactive ingredients.

Other: Placebo

Interventions

KiOnutrime®-Cs DEVICE

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.

KiOnutrime®-Cs

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kitozyme: lead
• Naturalpha: collaborator

Study Sites (1)

Clinical Nutrition Center Naturalpha (CNCN)

Lille, 59120, France

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Audrey DESCHAMPS, PhD

  Kitozyme, Belgium

  STUDY DIRECTOR

• Xavier DEPLANQUE, MD

  Clinical Nutrition Center Naturalpha, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 23, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

FR (1)