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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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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
Primary purpose
Allocation
Interventional model
Masking
108 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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