Safety and Efficacy of IQP-AK-102 in Reducing Appetite

Study Overview
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Brief Summary
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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.

Official Title
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Double Blind, Randomized, Placebo-controlled, Monocentric Clinical Investigation to Evaluate Efficacy of IQP-AK-102 on Appetite Reduction in Healthy Overweight and Obese Subjects

Conditions
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Weight Loss, Appetite Modulation (Focus of Study)

Intervention / Treatment
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* Device: IQP-AK-102
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years 25≤BMI≤35 Expressed desire for weight loss Accustomed to 3 main meals/day Generally in good health Consistent and stable body weight 3 months prior to study enrolment Consistent regular physical activity Commitment to avoid the use of other weight loss products during study Commitment to adhere to diet and lifestyle recommended for the study Exclusion Criteria: Known sensitivity to the ingredients of the device Presence of any active gastrointestinal disease Malabsorption disorders Pancreatitis Stenosis in the GI tract Bariatric surgery Any other reason deemed suitable for exclusion, per investigator's judgement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IQP-AK-102<br>2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water | Device: IQP-AK-102<br> <br> |
| Placebo Comparator: Placebo<br>2 capsules per dose, 3 times daily, 30-60 mins before each main meal with a full glass (250 mL) of water | Device: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |