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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1123-0658 | Other Identifier | WHO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyglucosamine | Device | ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body weight in kg | 24 weeks | |
| Change of BMI | 24 weeks | |
| Reduction of waist circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karina Pokhis, MD | Salztal Klinik GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salztal Klinik GmbH | Bad Soden-Salmünster | Hessia | 63628 | Germany | ||
| MAP Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26217540 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001835 | Body Weight |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| Placebo | Other | Placebo tablet |
|
| 24 weeks |
| Rende |
| Cosenza |
| 87036 |
| Italy |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |