Efficacy and Safety of Litramine in 1 Year Weight Loss Study

InQpharm

Status

Completed

Conditions

Weight Loss

Obesity; Excess Calories

Overweight and Obesity

Treatments

Dietary Supplement: Litramine

Dietary Supplement: Placebo tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT03227276

INQ/004317

Details and patient eligibility

About

To evaluate the efficacy of Litramine in reducing body weight in the context of an energy-restricted diet in overweight and moderately obese subjects

Enrollment

166 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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