Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246699
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : March 31, 2015
Sponsor:
Collaborator:
Naturalpha
Information provided by (Responsible Party):
Kitozyme

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.


Condition or disease Intervention/treatment Phase
Overweight and Obese Volunteers. Device: KiOnutrime®-Cs Other: Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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.




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


Secondary Outcome Measures :
  1. Anthropometric measurements [ Time Frame: 0 ; 30 ; 60 ; 90 days ]
    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.

  2. Body fat mass [ Time Frame: 0 - 90 days ]
    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.

  3. Hunger and satiety sensation [ Time Frame: -7 ; 0 ; 30 ; 60 ; 90 days ]
    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.

  4. Serum lipids [ Time Frame: 0 - 90 days ]
    Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in serum lipids (triglycerides and cholesterol) between KiOnutrime®-Cs and placebo.

  5. Blood pressure [ Time Frame: 0 ; 30 ; 60 ; 90 days ]
    Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in systolic and diastolic blood pressure between KiOnutrime®-Cs and placebo.

  6. Electrolytic measurements and fat-soluble vitamins [ Time Frame: 0 - 90 days ]
    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.

  7. Gastrointestinal tolerance [ Time Frame: -7 ; 0 ; 30 ; 60 ; 90 days ]
    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.

  8. Safety blood parameters [ Time Frame: 0 - 90 days ]
    Evaluation of the safety of KiOnutrime®-Cs through safety blood parameters measurements (urea, creatinine, glucose, Aspartate Aminotransferase and Alanine Aminotransferase).

  9. Adverse events [ Time Frame: Study duration ]
    Evaluation of the safety of KiOnutrime®-Cs through adverse events recording.

  10. Physical Activity score [ Time Frame: -7 ; 0 ; 30 ; 60 ; 90 days ]
    Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in Physical Activity score (via Physical activity questionnaire).

  11. Food recording [ Time Frame: 0 ; 30 ; 60 ; 90 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246699


Locations
Layout table for location information
France
Clinical Nutrition Center Naturalpha (CNCN)
Lille, France, 59120
Sponsors and Collaborators
Kitozyme
Naturalpha
Investigators
Layout table for investigator information
Study Director: Audrey DESCHAMPS, PhD Kitozyme, Belgium
Principal Investigator: Xavier DEPLANQUE, MD Clinical Nutrition Center Naturalpha, France

Layout table for additonal information
Responsible Party: Kitozyme
ClinicalTrials.gov Identifier: NCT02246699     History of Changes
Other Study ID Numbers: 14-041
ID-RCB Number : 2014-A01026-41 ( Other Identifier: ANSM )
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Kitozyme:
obesity
overweight
chitosan
fungal chitosan
weight management
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Body Weight
Weight Loss
Overnutrition
Nutrition Disorders
Signs and Symptoms
Body Weight Changes
Chitosan
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents
Hemostatics
Coagulants