Status:
COMPLETED
Efficacy and Safety of Litramine in 1 Year Weight Loss Study
Lead Sponsor:
InQpharm Group
Conditions:
Obesity; Excess Calories
Overweight and Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects
Eligibility Criteria
Inclusion
- Men and women from 18 to 70 years old
- Overweight (BMI 25 kg/m2 - 29.9 kg/m2) for 80% of randomized subjects and obese (BMI 30 kg/m2 - 34.9 kg/m2) for 20% of randomized subjects
- Generally in good health
- Desire to lose weight
- Readiness and ability to complete the 1-year study, according to investigator's judgement following the screening interview
- 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 avoid the use of other weight loss and/or management products and/or programs during the study
- to adhere to diet recommendation during the study
- to complete the subject diary and study questionnaires
- Women of childbearing potential:
- commitment to use contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- Written informed consent
Exclusion
- Known allergy or hypersensitivity to the components of the investigational products or source plants
- Pathological electrocardiogram (ECG) at V1
- History and/or presence of clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- untreated or unstable thyroid gland disorder
- untreated or unstable hypertension (regular blood pressure \>140/90 mm Hg)
- 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 unstable diabetes mellitus type 2
- any other serious organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject
- 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 3 months prior to V1 and during the study:
- that could influence body weight (e.g. systemic corticosteroids)
- that could influence gastrointestinal functions (e.g. laxatives, opioids, anticholinergics etc.) as per investigator judgement
- for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.)
- 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)
- 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, e.g. insufficient compliance with study procedures
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03227276
Start Date
August 14 2017
End Date
February 19 2020
Last Update
February 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Analyze & Realize
Berlin, Germany, 10369