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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose IQP-LU-104 (5120mg) | Experimental | High dose treatment group |
|
| Low dose IQP-LU-104 (2560mg) | Experimental | Low dose treatment group |
|
| Placebo | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose IQP-LU-104 (5120mg) | Dietary Supplement | 1 sachet to be taken 2 times daily orally, together with 2 main meals |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters (lab parameters and vital signs) | Assessment of laboratory results in full blood count, clinical chemistry, blood pressure and pulse rate | 12 weeks |
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:
Women of childbearing potential:
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.:
Significant surgery within the last 6 months prior to V1:
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:
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.:
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
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| Name | Affiliation | Role |
|---|---|---|
| Udo Bongartz, MD, PhD | Analyze & Realize | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analyze & Realize | Berlin | 10369 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35130547 | Derived | Bongartz U, Hochmann U, Grube B, Uebelhack R, Alt F, Erlenbeck C, Peng LV, Chong PW, De Costa P. Flaxseed Mucilage (IQP-LU-104) Reduces Body Weight in Overweight and Moderately Obese Individuals in a 12-week, Three-Arm, Double-Blind, Randomized, and Placebo-Controlled Clinical Study. Obes Facts. 2022;15(3):395-404. doi: 10.1159/000522082. Epub 2022 Feb 7. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Low dose IQP-LU-104 (2560mg) | Dietary Supplement | 1 sachet to be taken 2 times daily orally, together with 2 main meals |
|
| Placebo | Dietary Supplement | 1 sachet to be taken 2 times daily orally, together with 2 main meals |
|
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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |