Overweight and Obese Volunteers.NCT02246699
Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers
A study testing KiOnutrime®-Cs in people with Overweight and Obese Volunteers., run by Kitozyme at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight and Obese Volunteers.
- What is being tested?
- KiOnutrime®-Cs
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Overweight and Obese Volunteers.
- Being tested
- KiOnutrime®-Cs, Placebo
- Keywords
- obesity, overweight, chitosan, fungal chitosan, weight management
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KiOnutrime®-CsDevice
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| KiOnutrime®-Cs | Experimental | The product is presented as a capsule containing chitosan as ingredient supporting the activity. Receives: Device: KiOnutrime®-Cs |
| Placebo | Placebo comparator | Placebo is presented as a capsule containing inactive ingredients. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 ; 30 ; 60 ; 90 days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: -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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: -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).
Measured: 0 - 90 days
Adverse events
Evaluation of the safety of KiOnutrime®-Cs through adverse events recording.
Measured: 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).
Measured: -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.
Measured: 0 ; 30 ; 60 ; 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and Obese Volunteers.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kitozyme
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Naturalpha
- Responsible party
- Sponsor
- Investigators
- Audrey DESCHAMPS, PhD, Study director, Kitozyme, BelgiumXavier DEPLANQUE, MD, Principal investigator, Clinical Nutrition Center Naturalpha, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246699
- Sponsor's protocol ID
- 14-041
- Other IDs
- ID-RCB Number : 2014-A01026-41
- Status last verified
- Mar 2015
- First submitted
- 19 Sep 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02246699
- Acronym / sponsor ID
- 14-041
- Conditions
- Overweight and Obese Volunteers.
- Keywords
- obesity, overweight, chitosan, fungal chitosan, weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- KitozymeIndustry (pharma, biotech, devices)
- Collaborators
- Naturalpha
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KiOnutrime®-Cs | Experimental | Device: KiOnutrime®-CsThe product is presented as a capsule containing chitosan as ingredient supporting the activity. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo is presented as a capsule containing inactive ingredients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KiOnutrime®-CsThe 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. | Device | KiOnutrime®-Cs |
| PlaceboThe 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. | Other | Placebo |
Primary outcome
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.
11 secondary outcomes
Anthropometric measurements
Time frame: 0 ; 30 ; 60 ; 90 days
Body fat mass
Time frame: 0 - 90 days
Hunger and satiety sensation
Time frame: -7 ; 0 ; 30 ; 60 ; 90 days
Serum lipids
Time frame: 0 - 90 days
Blood pressure
Time frame: 0 ; 30 ; 60 ; 90 days
Electrolytic measurements and fat-soluble vitamins
Time frame: 0 - 90 days
Gastrointestinal tolerance
Time frame: -7 ; 0 ; 30 ; 60 ; 90 days
Safety blood parameters
Time frame: 0 - 90 days
Adverse events
Time frame: Study duration
Physical Activity score
Time frame: -7 ; 0 ; 30 ; 60 ; 90 days
Food recording
Time frame: 0 ; 30 ; 60 ; 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey DESCHAMPS, PhD study director
Kitozyme, Belgium
Xavier DEPLANQUE, MD principal investigator
Clinical Nutrition Center Naturalpha, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KiOnutrime®-Cs in people with Overweight and Obese Volunteers., run by Kitozyme at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 0 ; 30 ; 60 ; 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.