Overweight and ObesityNCT02410785
Efficacy of Polyglucosamine for Weight Loss
A study testing Polyglucosamine in people with Overweight and Obesity, run by Certmedica International GmbH at 2 sites in 2 countries.
Trial summary
The polyglucosamine, specification L112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Polyglucosamine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2009to Oct 2010
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 26 and < 45
- 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 and known hypersensitivity reactions to crustaceans
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
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 of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.
Read the detailed description
To have a comparable diet condition, all participants in both groups had to follow the recommendations of the German clinical practice guidelines on the management and prevention of obesity.
One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. 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 in 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
- Overweight and Obesity
- Being tested
- Polyglucosamine, Placebo
- Keywords
- obesity,, body weight,, overweight,, weight loss,, polyglucosamine,, L112, caloric restriction, physical activity
- Medical subject headings
- Overweight, Obesity, Body Weight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyglucosamineDevice
ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
PlaceboOther
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Medical device polyglucosamine | Active comparator | 2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity. Receives: Device: Polyglucosamine |
| Placebo | Placebo comparator | 2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased 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 5 or more per cent compared to the initial body weight.
Measured: 24 weeks
Secondary outcomes (3)
Change of body weight in kg
Measured: 24 weeks
Change of BMI
Measured: 24 weeks
Reduction of waist circumference
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Certmedica International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karina Pokhis, MD, Principal investigator, Salztal Klinik GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410785
- Sponsor's protocol ID
- 001/09
- Other IDs
- U1111-1123-0658
- Status last verified
- Mar 2015
- First submitted
- 27 Mar 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pokhis K, Bitterlich N, Cornelli U, Cassano G. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation. BMC Obes. 2015 Jun 10;2:25. doi: 10.1186/s40608-015-0053-5. eCollection 2015.
PubMed 26217540
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. 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
- NCT02410785
- Acronym / sponsor ID
- 001/09
- Conditions
- Overweight and Obesity
- Keywords
- obesity,, body weight,, overweight,, weight loss,, polyglucosamine,, L112, caloric restriction, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Certmedica International GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Apr 2015 (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 of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.
Detailed description
To have a comparable diet condition, all participants in both groups had to follow the recommendations of the German clinical practice guidelines on the management and prevention of obesity.
One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. 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 in 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: Polyglucosamine2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity. |
| Placebo | Placebo comparator | Other: Placebo2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI > 26 and < 45
- waist circumference of more than 88 cm for women and greater than 102 for men.
Key exclusion criteria (1 listed)
- 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 and known hypersensitivity reactions to crustaceans
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 |
|---|---|---|
| Polyglucosamineß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans | Device | Medical device polyglucosamine |
| PlaceboPlacebo tablet | Other | Placebo |
Primary outcome
Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.
Time frame: 24 weeks
3 secondary outcomes
Change of body weight in kg
Time frame: 24 weeks
Change of BMI
Time frame: 24 weeks
Reduction of waist circumference
Time frame: 24 weeks
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 28 Jan 2016.
- Derived from this study: PubMed 26217540Pokhis K, Bitterlich N, Cornelli U, Cassano G. Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation. BMC Obes. 2015 Jun 10;2:25. doi: 10.1186/s40608-015-0053-5. eCollection 2015.
- 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.
Karina Pokhis, MD principal investigator
Salztal Klinik GmbH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyglucosamine in people with Overweight and Obesity, run by Certmedica International GmbH at 2 sites in 2 countries.
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 1 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, 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 5 or more per cent compared to the initial body weight. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02410785, which also lists 1 linked publication.
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 28 Jan 2016.