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To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucosanol | Active Comparator | 2 tablets 3 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosanol | Device | 2 tablets taken 3 times a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Measured in kg using a calibrated scale | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Waist and hip circumference (cm) | Changes from baseline to end of study | 24 weeks |
| Body mass index, BMI (kg/m2) | Changes from baseline to end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Grube, MD | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24006357 | Derived | Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| 24 weeks |
| Body fat content and fat free mass | Changes from baseline to end of study | 24 weeks |
| Effect on appetite, hunger and food cravings | The Control of Eating Questionnaire (COEQ) is used | 24 weeks |
| Feeling of satiety | A 4-point categorical scale is used | 24 weeks |
| Evaluation of the efficacy of Glucosanol by the subjects | A 4-point categorical scale is used | 24 weeks |
| Full blood count | Done at baseline and end of study | 24 weeks |
| Clinical chemistry parameter | Done at baseline and end of study | 24 weeks |
| Blood pressure | Measured in mm Hg | 24 weeks |
| Global evaluation of the safety of Glucosanol by the subjects | A 4-point categorical scale is used. | 24 weeks |
| Global evaluation of the safety of Glucosanol by the investigators | A 4-point categorical scale is used | 24 weeks |
| Occurrence of adverse events | All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms | 24 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |