ObesityNCT02682277
Efficacy of Polyglucosamine Long Term Treatment
A study testing polygucosamine in people with Obesity, run by Certmedica International GmbH at 1 site in Italy.
Trial summary
The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- polygucosamine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to 31 Oct 2016
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >30 and < 35
- waist circumference of more than 88 cm for women and greater than 102 for men
Who cannot join
- pregnancy or breast-feeding
- alcohol abuse
- drug abuse or drug addiction
- inability to fulfill the criteria of the trial protocol
- cancer diseases
- malignant tumors
- pre-existence of chronic intestinal disease
- known hypersensitivity reactions to crustaceans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation
The polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.
Read the detailed description
Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.
One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.
- Conditions
- Obesity
- Being tested
- polygucosamine, placebo
- Keywords
- obesity, body weight, overweight, weight loss, polyglucosamine, L112, caloric restriction, physical activity
- Medical subject headings
- Obesity, Body Weight, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polygucosamineDevice
Also called ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine
2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
placeboOther
2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Medical device polyglucosamine | Active comparator | 2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity Receives: Device: polygucosamine |
| Placebo | Placebo comparator | 2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.
Measured: 12 months
Secondary outcomes (3)
Change of body weight in kg
Measured: 12 months
Change of BMI
Measured: 12 monts
Reduction of waist circumference
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startMay 2014
- Primary completionOct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gianni Belcaro, Principal investigator, Irwine Labs University of ChietiUmberto Cornelli, MD, Study director, Loyola University School of Medicine-Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682277
- Sponsor's protocol ID
- 003/14
- Other IDs
- U111111292405
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation
- ClinicalTrials.gov ID
- NCT02682277
- Acronym / sponsor ID
- 003/14
- Conditions
- Obesity
- Keywords
- obesity, body weight, overweight, weight loss, polyglucosamine, L112, caloric restriction, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 15 Feb 2016 (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 polyglucosamine, specification L112, is a medical device and in this clinical trial used for weight reduction in moderately obese participants following a long term treatment lasting 12 months. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals.
Detailed description
Two groups of subjects were compared. A comparable diet condition, consisting of 10 % reduction of caloric intake was followed, according to a questionnaire based on the weekly number of servings. No modification of physical activity was requested.
One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 12 months. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex is unable to pass the gut wall into the body but is naturally excreted,hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical device polyglucosamine | Active comparator | Device: polygucosamine2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity |
| Placebo | Placebo comparator | Other: placebo2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >30 and < 35
- waist circumference of more than 88 cm for women and greater than 102 for men
Key exclusion criteria (8 listed)
- pregnancy or breast-feeding
- alcohol abuse
- drug abuse or drug addiction
- inability to fulfill the criteria of the trial protocol
- cancer diseases
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 |
|---|---|---|
| polygucosamineAlso: ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity. | Device | Medical device polyglucosamine |
| placebo2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity. | Other | Placebo |
Primary outcome
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight.
Time frame: 12 months
3 secondary outcomes
Change of body weight in kg
Time frame: 12 months
Change of BMI
Time frame: 12 monts
Reduction of waist circumference
Time frame: 12 months
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 25 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Gianni Belcaro principal investigator
Irwine Labs University of Chieti
Umberto Cornelli, MD study director
Loyola University School of Medicine-Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polygucosamine in people with Obesity, run by Certmedica International GmbH at 1 site in Italy.
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 2 inclusion and 8 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 25 Jul 2017. 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 Italy. 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?
Number of participants who could reduce their body weight by 10 or more per cent compared to the initial body weight. (time frame: 12 months). 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 25 Jul 2017.