Back to resultsEfficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers
Primary Purpose
Overweight and Obese Volunteers.
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
KiOnutrime®-Cs
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obese Volunteers. focused on measuring obesity, overweight, chitosan, fungal chitosan, weight management
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.
Sites / Locations
- Clinical Nutrition Center Naturalpha (CNCN)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KiOnutrime®-Cs
Placebo
Arm Description
The product is presented as a capsule containing chitosan as ingredient supporting the activity.
Placebo is presented as a capsule containing inactive ingredients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Safety blood parameters
Evaluation of the safety of KiOnutrime®-Cs through safety blood parameters measurements (urea, creatinine, glucose, Aspartate Aminotransferase and Alanine Aminotransferase).
Adverse events
Evaluation of the safety of KiOnutrime®-Cs through adverse events recording.
Physical Activity score
Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in Physical Activity score (via Physical activity questionnaire).
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.
Full Information
NCT ID
NCT02246699
First Posted
September 19, 2014
Last Updated
March 30, 2015
Sponsor
Kitozyme
Collaborators
Naturalpha
1. Study Identification
Unique Protocol Identification Number
NCT02246699
Brief Title
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kitozyme
Collaborators
Naturalpha
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obese Volunteers.
Keywords
obesity, overweight, chitosan, fungal chitosan, weight management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KiOnutrime®-Cs
Arm Type
Experimental
Arm Description
The product is presented as a capsule containing chitosan as ingredient supporting the activity.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is presented as a capsule containing inactive ingredients.
Intervention Type
Device
Intervention Name(s)
KiOnutrime®-Cs
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Body weight
Description
Comparison of the reduction of body weight, from baseline (randomization visit) to end-point (3 months of treatment), between KiOnutrime®-Cs and placebo arms.
Time Frame
0 ; 30 ; 60 ; 90 days
Secondary Outcome Measure Information:
Title
Anthropometric measurements
Description
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.
Time Frame
0 ; 30 ; 60 ; 90 days
Title
Body fat mass
Description
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.
Time Frame
0 - 90 days
Title
Hunger and satiety sensation
Description
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.
Time Frame
-7 ; 0 ; 30 ; 60 ; 90 days
Title
Serum lipids
Description
Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in serum lipids (triglycerides and cholesterol) between KiOnutrime®-Cs and placebo.
Time Frame
0 - 90 days
Title
Blood pressure
Description
Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in systolic and diastolic blood pressure between KiOnutrime®-Cs and placebo.
Time Frame
0 ; 30 ; 60 ; 90 days
Title
Electrolytic measurements and fat-soluble vitamins
Description
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.
Time Frame
0 - 90 days
Title
Gastrointestinal tolerance
Description
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.
Time Frame
-7 ; 0 ; 30 ; 60 ; 90 days
Title
Safety blood parameters
Description
Evaluation of the safety of KiOnutrime®-Cs through safety blood parameters measurements (urea, creatinine, glucose, Aspartate Aminotransferase and Alanine Aminotransferase).
Time Frame
0 - 90 days
Title
Adverse events
Description
Evaluation of the safety of KiOnutrime®-Cs through adverse events recording.
Time Frame
Study duration
Title
Physical Activity score
Description
Mean changes from baseline (randomization visit) to end-point (3 months of treatment) in Physical Activity score (via Physical activity questionnaire).
Time Frame
-7 ; 0 ; 30 ; 60 ; 90 days
Title
Food recording
Description
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.
Time Frame
0 ; 30 ; 60 ; 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey DESCHAMPS, PhD
Organizational Affiliation
Kitozyme, Belgium
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xavier DEPLANQUE, MD
Organizational Affiliation
Clinical Nutrition Center Naturalpha, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition Center Naturalpha (CNCN)
City
Lille
ZIP/Postal Code
59120
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers
We'll reach out to this number within 24 hrs