Benefit and Tolerability of IQP-AE-103 in Weight Loss

Study Overview
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Brief Summary
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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

Official Title
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Double-blind, Randomised, 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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: IQP-AE-103 (330mg)
* Dietary Supplement: IQP-AE-103 (165mg)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years Overweight to moderately obese subjects (BMI ≥ 25 and < 35 kg/m2) Expressed desire for weight loss Accustomed to 3 main meals/day Commitment to take IP as recommended Commitment to adhere to diet recommendation during the study Commitment to maintain habitual level of activity/exercise during the study Consistent and stable body weight for 3 months prior to V1 Commitment to avoid the use of other weight management products or programs during study Commitment and ability to complete the subject diary and study questionnaires Females of childbearing potential: negative pregnancy testing (beta HCG-test in urine) at V1, agreement to use appropriate contraception methods during the study period Consents to participate, understands requirements of the study and is willing to comply Exclusion Criteria: Known sensitivity to the ingredients of the investigational product or source of ingredients Pregnancy or nursing Smoking cessation within 6 months prior to V1 or during the study (regular smoking during the study at the same level as prior to the study is allowed) Current or history of abuse of drugs, alcohol or medication Clinically relevant excursions of safety laboratory parameter Diabetes mellitus type 1 Untreated or unstable diabetes mellitus type 2 Untreated or unstable endocrine disorders which may influence body weight (e.g. Cushing's disease, thyroid gland disorders) Stenosis in the gastrointestinal (GI) tract Bariatric surgery in subject´s medical history Abdominal surgery within the last 6 months prior to V1 Current use of medications that may affect body weight (eg. antipsychotics, anti-depressants, corticosteroids etc.) Presence of acute or chronic gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease, pancreatitis) Digestion/absorption disorders in gastrointestinal (GI) tract History of eating disorders such as bulimia, anorexia nervosa within the past 12 months prior to V1 Other serious organ or systemic diseases such as cancer within the last 5 years prior to V1 Any electronic medical implant Use of any medication that could influence GI functions such as antibiotics within 4 weeks and any laxatives, opioids, glucocorticoids, anticholinergics within last 3 months prior to V1 and during the study, as per investigator judgement Any medication or use of products for the treatment of obesity (e.g. orlistat, other fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.) within last 3 months prior to V1 and during the study Participation in similar studies or weight loss programs within last 4 weeks prior to V1 Participation in other studies during the last 4 weeks prior to V1 Inability to comply Presence of other factor(s) or medication that should preclude subject participation as per investigator 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose IQP-AE-103 (1980mg)<br>2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks | Dietary Supplement: IQP-AE-103 (330mg)<br>* High dose capsules<br>|
| Experimental: Low dose IQP-AE-103 (990mg)<br>2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks | Dietary Supplement: IQP-AE-103 (165mg)<br>* Low dose capsules<br>|
| Placebo Comparator: Placebo<br>2 capsules IQP-AE-103 by mouth, three times a day after main meals for 12 weeks | Dietary Supplement: Placebo<br>* Placebo identical to verum capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 (%) | 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 |