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The primary cause of being overweight is an imbalance in calories consumed and energy expenditure. A surplus in energy intake might result in body fat deposition and thereby body weight gain. Therefore, food intake regulation is crucial to control the body weight gain.
Appetite regulation plays an important role in determining the food intake, which is a complex process influenced by the individual (physiology and psychology) and environment. Satiation (process that leads to the termination of eating) and satiety (decline in hunger, increase in fullness after a meal has finished) are the precursors of appetite regulation, which may be induced by various food components such as macronutrients, water, alcohol and non-digestible polysaccharides. High viscosity and swellable/bulking food components such as dietary fibre are expected to elicit stronger satiation/satiety than the macronutrients or clear liquid. Due to its unique physicochemical properties, dietary fibre has been recognized as potential ingredient that helps to enhance the sensation of satiety in the upper gut by increasing gastric distension and delaying gastric emptying, which subsequently reduces the food intake.
IQP-AK-102 comprises of a proprietary blend of dietary fibres known to promote a feeling a fullness. The objectives of this study are to evaluate the efficacy and safety of IQP-AK-102 on appetite reduction in overweight subjects during a 4-weeks interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IQP-AK-102 | Experimental | 2 capsules to be taken 3 times daily orally, 30 min before each main meal (breakfast, lunch, dinner) with 250 mL of water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IQP-AK-102 | Device | IQP-AK-102 has been qualified as a medical device (CE certificate has been ob- tained), class IIb, according to MDD 93/42/EEC, annex IX, rule 5. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in appetite before and after breakfast 3 days a week (including one weekend day) using Haber Score (hunger, satiety) | - Comparison between week 2 and week 3 (first week of the IP intake) as well as comparison between week 2 and week 6 (last week of the IP intake) | 6 weeks |
| Changes in appetite before and after breakfast 3 days a week (including one weekend day) using VAS (hunger, satiety, fullness, prospective food consumption). | - Comparison between week 2 and week 3 (first week of the IP intake) as well as comparison between week 2 and week 6 (last week of the IP intake) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in food intake using the subject diary | Measured on the same days as appetite assessment (for breakfast, lunch, dinner, in between meal/snacks), during the run-in phase (three days a week, both weeks) and treatment phase (at first week of the IP intake (week 3),and during the last week of the IP intake, just before the V3, also three days a week). | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, MD, PhD | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Grube | Berlin | 10709 | Germany |
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| Changes in body weight using calibrated weighing scales (Tanita BC-420 SMA) | Body weight (kg) is measured in subjects wearing underwear and no shoes | 6 weeks |
| Changes in BMI | BMI is calculated as body weight (kg)/(height [m])2 | 6 weeks |
| Changes in waist circumference | Waist circumference (cm) is measured at the level midway between the lateral lower rib margin and the iliac crest | 6 weeks |
| Changes in hip circumference | Hip circumference (cm) is measured as the maximal circumference over the buttocks | 6 weeks |
| Changes in body fat content using validated electronic weighing scales according to the Body composition analyser BC-420MA (a bio-impedance analysis (BIA)) | Measured as % and kg | 6 weeks |
| Changes in fat-free mass using validated electronic weighing scales according to the Body composition analyser BC-420MA (a bio-impedance analysis (BIA)) | Measured as % and kg | 6 weeks |
| Global evaluation of efficacy by subjects | The subjects will evaluate independently the efficacy of the IP (globally scaled evaluation with "very good", "good", "moderate" and "poor"). | 6 weeks |
| Global evaluation of efficacy by investigator | The investigators will evaluate independently the efficacy of the IP (globally scaled evaluation with "very good", "good", "moderate" and "poor"). | 6 weeks |
| Blood pressure | Measured using standard devices after an at least 5-minute rest | 6 weeks |
| Pulse rate | Measured using standard devices after an at least 5-minute rest | 6 weeks |
| Global evaluation of safety by subjects | The subjects will evaluate independently the tolerability of the IP (global scaled evaluation with "very good", "good", "moderate" and "poor"). | 6 weeks |
| Global evaluation of safety by investigator | The investigators will evaluate independently the tolerability of the IP (global scaled evaluation with "very good", "good", "moderate" and "poor"). | 6 weeks |