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The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation, aiming to reduce the appetite.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQP-AK-102 | Active Comparator | 2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water |
|
| Placebo | Placebo Comparator | 2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQP-AK-102 | Device |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of VAS between two study arms measured from time '0 to '240 during baseline visit and the final visit | Measured using a visual analogue scale (VAS) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in ad libitum energy intake between the two arms at baseline visit and at final visit | Measured in kcal | 4 weeks |
| Change in "difference in ad libitum energy intake between two study arms", from baseline visit to the final visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Udo Bongartz, MD | Analyze & Realize | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Udo Bongartz | Berlin | State of Berlin | 10369 | Germany |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
Measured in kcal
| 4 weeks |
| Difference in subjective appetite sensations (VAS) between baseline and the final visit for the two study arms | Measured using VAS | 4 weeks |
| Difference in the mean change in body weight between the 2 arms, from baseline to the final visit | Measured in kg. Subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA) | 4 weeks |
| Changes in waist and hip circumference | Measured in cm. Waist: measured at the level midway between the lateral lower rib margin and the iliac crest Hip: measured as the maximal circumference over the buttocks | 4 weeks |
| Changes in body fat content and fat free mass | Measured in % and kg using bio-impedence method using validated electronic weighing scales (Tanita BC-420 SMA) | 4 weeks |
| Subjects global feeling of satiety | 4 weeks |
| Food Craving Questionnaire | 15 questions | 4 weeks |
| Global evaluation of efficacy by the subjects and investigators | 4 weeks |
| Global evaluation of safety by the subjects and investigators | 4 weeks |