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This study is to evaluate the benefit and tolerability of two dosages of IQP-AE-103 (990mg and 1980mg daily) in reducing body weight in overweight and moderately obese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose IQP-AE-103 (1980mg) | Experimental | 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks |
|
| Low dose IQP-AE-103 (990mg) | Experimental | 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks |
|
| Placebo | Placebo Comparator | 2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQP-AE-103 (330mg) | Dietary Supplement | High dose capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in body weight (kg) | Difference in mean change of body weight (kg) between the higher dosed verum (1980 mg a day) and placebo group after 12 weeks of intervention in comparison to baseline. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in body weight (kg) | Changes in body weight (kg) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group | 2, 4, 8, 12 weeks |
| Mean change in body weight (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters (lab parameters, vital signs) | Change in safety lab parameters, vital signs | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analyze & Realize | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35571928 | Derived | Peng LV, Cooper J, De Costa P, Chong PW. Microbiota Composition and Diversity in Weight Loss Population After the Intake of IQP-AE-103 in a Double-Blind, Randomized, Placebo-Controlled Study. Front Nutr. 2022 Apr 28;9:790045. doi: 10.3389/fnut.2022.790045. eCollection 2022. | |
| 30863632 | Derived | Uebelhack R, Bongartz U, Seibt S, Bothe G, Chong PW, De Costa P, Wszelaki N. Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects. J Obes. 2019 Feb 3;2019:3412952. doi: 10.1155/2019/3412952. eCollection 2019. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| IQP-AE-103 (165mg) |
| Dietary Supplement |
Low dose capsules |
|
| Placebo | Dietary Supplement | Placebo identical to verum capsules |
|
Changes in body weight (%) after 2, 4, 8, and 12 weeks of intervention, each in comparison to baseline, between the two active and placebo group
| 2, 4, 8, 12 weeks |
| Proportion of subject weight loss | Proportion of subjects who lost at least 3% and 5% of baseline body weight after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline | 2, 4, 8, 12 weeks |
| Change in waist circumference (cm) | Changes in waist circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline | 2, 4, 8, 12 weeks |
| Change in hip circumference (cm) | Changes in hip circumference after 2, 4, 8, and 12 weeks intervention, each in comparison to baseline | 2, 4, 8, 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |