Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Glucosanol had previously been proven to be effective in aiding weight loss and weight loss maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was effective in aiding weight loss and also has evidence on reducing post-prandial glucose levels. This study is to enrich the existing evidence on dose-dependent post-prandial glucose effects of Glucosanol
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Four capsules of placebo to be taken 30 mins before each test meal at the investigator's site |
|
| Glucosanol 1000mg | Experimental | Two capsules of placebo and two capsules of Glucosanol 500mg capsules to be taken 30 mins before each test meal at the investigator's site |
|
| Glucosanol 2000mg | Experimental | Four capsules of Glucosanol 500mg to be taken 30 mins before each test meal at the investigator's site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosanol 500mg | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total PPG between verum 1000mg and 2000mg study arms vs the placebo study arm | Change defined as incremental AUC0 - AUC120min in mmol/(L*min) | 120 mins |
Not provided
Not provided
Inclusion Criteria:
Caucasian males and females, 18 to 65 years old
Body mass index (BMI) 25.0-29.9 kg/m2
Generally in good health
Normal fasting blood glucose (FBG) 3.9- <5.6 mmol/L (70- <100 mg/dL) and glycated hemoglobin HbA1c of 4- <5.7 %
Readiness to adhere to consumption of test meals and defined restrictions prior to test meals (refer to section 11.8 for details)
Readiness to adhere to habitual lifestyle during the study, in particular to:
to the study and no smoking on days of test meals
prior and during the visit
Stable body weight in the last 3 months prior to V1 (≤5% self-reported change)
Stable concomitant medications (if any) for at least last 3 months prior to V1
Women of child-bearing potential only:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, MD | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| analyze & realize GmbH | Berlin | State of Berlin | D-13467 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
|