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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Litramine

Active Comparator group

Description:

2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Treatment:

Device: Litramine

Placebo

Placebo Comparator group

Description:

2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Treatment:

Device: Placebo

Sponsor of this trial

Lead Sponsor

InQpharm