Benefit and Tolerability of IQP-LU-104 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-LU-104 (5120mg and 2560mg daily) in reducing body weight in overweight and moderately obese subjects

Official Title
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Double-blind, Randomized, Three-armed, Placebo-controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-LU-104 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: High dose IQP-LU-104 (5120mg)
* Dietary Supplement: Low dose IQP-LU-104 (2560mg)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years Overweight (BMI 25 to < 30 kg/m2) and moderately obese (BMI 30 to < 35 kg/m2) subjects Generally in good health Desire to lose weight Accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner) Consistent and stable body weight in the last 3 months prior to V1 (less than 5% self-reported change) Subject's agreement to comply with study procedures, in particular: to take IP as recommended to follow diet recommendation during the study to complete the subject diary and study questionnaires to maintain the habitual level of physical activity during the study Women of childbearing potential: commitment to use contraception methods negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1 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 History and/or presence of clinically significant condition/disorder, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.: untreated or non-stabilised thyroid gland disorder untreated or non-stabilised hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) acute or chronic gastrointestinal (GI) disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) diabetes mellitus type 1 untreated or non-stabilised diabetes mellitus type 2 any other relevant serious organ or systemic diseases Significant surgery within the last 6 months prior to V1: GI surgery liposuction History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 months prior to V1 Deviation of safety laboratory parameter(s) at V1 that is: clinically significant or > 2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome) Any electronic medical implant Regular medication and/or supplementation and/or treatment within the last month prior to V1 and during the study, which per investigator's judgment could interfere with the results of the study or the safety of the subject, e.g.: that could influence body weight (e.g. systemic cortcosteroids, antipsychotics, anti-depressants) that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, anticholinergics etc.) as per investigator judgment for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products etc.) any other relevant medication and/or supplementation Diet/weight loss programs within the last 3 months prior to V1 and during the study 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) Vegetarian, vegan or other restrictive diet Women of child-bearing potential: pregnancy or nursing History of or current abuse of drugs, alcohol or medication Participation in another clinical study in the 30 days prior to V1 and during the study Any other reason for exclusion as per investigator's judgment

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-LU-104 (5120mg)<br>High dose treatment group | Dietary Supplement: High dose IQP-LU-104 (5120mg)<br>* 1 sachet to be taken 2 times daily orally, together with 2 main meals<br>|
| Experimental: Low dose IQP-LU-104 (2560mg)<br>Low dose treatment group | Dietary Supplement: Low dose IQP-LU-104 (2560mg)<br>* 1 sachet to be taken 2 times daily orally, together with 2 main meals<br>|
| Placebo Comparator: Placebo<br>Placebo group | Dietary Supplement: Placebo<br>* 1 sachet to be taken 2 times daily orally, together with 2 main meals<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 and placebo group after 12 weeks of intervention in comparison to baseline | 12 weeks | 
| Mean change in body weight (kg) | Difference in mean change of body weight (kg) between the lower dosed verum 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) | Difference between the higher dosed verum and placebo group in mean change of body weight (kg) after 4 and 8 weeks of intervention, each in comparison to baseline | 4 and 8 weeks | 
| Mean change in body weight (kg) | Difference between the lower dosed verum and placebo group in mean change of body weight (kg) after 4 and 8 weeks of intervention, each in comparison to baseline | 4 and 8 weeks | 
| Body weight (kg) | Difference between the two verum and placebo groups in body weight (kg) after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in body weight percentage (%) | Difference between the two verum and placebo groups in the changes in body weight (%) after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Proportion of subjects with weight loss | Difference between the two verum and placebo groups in the proportion of subjects who lost at least 3%, 5% and 10% of baseline body weight after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Waist circumference (cm) | Difference between the two verum and placebo groups in waist circumference (cm) after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in waist circumference (cm) | Difference between the two verum and placebo groups in the changes in waist circumference (cm) after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Hip circumference (cm) | Difference between the two verum and placebo groups in hip circumference (cm) after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in hip circumference (cm) | Difference between the two verum and placebo groups in the changes in hip circumference (cm) after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Waist-hip ratio | Difference between the two verum and placebo groups in waist-hip ratio after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in waist-hip ratio | Difference between the two verum and placebo groups in the changes in waist-hip ratio after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| BMI (kg/m^2) | Difference between the two verum and placebo groups in BMI (kg/m^2) after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in BMI (kg/m^2) | Difference between the two verum and placebo group in the changes in BMI (kg/m^2) after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Body fat percentage (%) | Difference between the two verum and placebo groups in body fat (%) after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in body fat percentage (%) | Difference between the two verum and placebo groups in the changes in body fat (%) after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Body fat mass (kg) | Difference between the two verum and placebo groups in body fat mass (kg) after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in body fat mass (kg) | Difference between the two verum and placebo groups in the changes in body fat mass (kg) after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Fat free mass (kg) | Difference between the two verum and placebo groups in fat free mass (kg) after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in fat free mass (kg) | Difference between the two verum and placebo groups in the changes in fat free mass (kg) after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Evaluation of feeling of hunger using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the evaluation of feelings of hunger using VAS after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in the evaluation of feeling of hunger using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the changes in evaluation of feelings of hunger using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Evaluation of feeling of satiety using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the evaluation of feelings of satiety using VAS after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in the evaluation of feeling of satiety using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the changes in evaluation of feelings of satiety using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Evaluation of feeling of fullness using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the evaluation of feelings of fullness using VAS after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in the evaluation of feeling of fullness using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the changes in evaluation of feelings of fullness using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Evaluation of feeling of craving using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the evaluation of feelings of craving using VAS after 4, 8, and 12 weeks of intervention | 4, 8, 12 weeks | 
| Change in the evaluation of feeling of craving using visual analogue scales (VAS) | Difference between the two verum and placebo groups in the changes in evaluation of feelings of craving using VAS after 4, 8, and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Change in the quality of life using Impact of Weight on Quality of Life (IWQOL-Lite) Questionnaire | Difference between the two verum and placebo groups in the changes in quality of life using (IWQOL-Lite) questionnaire after 4, 8 and 12 weeks of intervention, each in comparison to baseline | 4, 8, 12 weeks | 
| Lipid metabolism parameters (mmol/l) | Difference between the two verum and placebo groups in total cholesterol (mmol/l), LDL-cholesterol (mmol) and HDL cholesterol (mmol) after 12 weeks of intervention | 12 weeks | 
| Change in lipid metabolism parameters (mmol/l) | Difference between the two verum and placebo groups in the changes in lipid metabolism parameters after 12 weeks of intervention, each in comparison to baseline | 12 weeks | 
| HbA1C percentage (%) | Difference between the two verum and placebo groups in HbA1C (%) after 12 weeks of intervention | 12 weeks | 
| Change in HbA1C percentage (%) | Difference between the two verum and placebo groups in the changes in HbA1C (%) after 12 weeks of intervention, each in comparison to baseline | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flaxseed mucilage, Weight loss, Satiety