Effect of Litramine on Fat Excretion

InQpharm

Status and phase

Completed

Phase 4

Conditions

Healthy Subjects

Treatments

Device: Litramine

Device: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01590667

INQ/028711

Details and patient eligibility

About

The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

BMI 20-30 kg/m2
Accustomed to 3 main meals/day
Commitment to avoid the use of other weight management products during study
Females' agreement to use appropriate birth control methods during the active study period
Self-reported regular bowel movement (1-2 times per day)
Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion criteria

Known sensitivity to the ingredients of the device
Diabetes mellitus (type 1 or 2)
History or clinical signs of endocrine disorders
Clinically relevant excursions of safety parameter
Current use of anti-depressants
Presence of acute or chronic gastrointestinal disease
Uncontrolled hypertension (more than 160/110 mm Hg)
Stenosis in the gastrointestinal tract
Bariatric surgery
Abdominal surgery within the last 6 months prior to enrollment
History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
Other serious organ or systemic diseases such as cancer
Any medication that could influence gastrointestinal functions
Pregnancy or nursing
Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment
History of abuse of drugs, alcohol or medication
Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation