Clinical trial NCT01590667: Effect of Litramine on Fat Excretion
Official title: Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects
Keywords: Fat excretion
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2012-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention
timeFrame: 7 days per intervention
Secondary outcomes:
measure: Full blood count
timeFrame: Approximately 45 days
measure: Clinical chemistry
timeFrame: Approximately 45 days
measure: Blood pressure
timeFrame: Approximately 45 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Weißenseer Weg 111
Study officials:
affiliation: analyze & realize AG
name: Regina Busch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uebelhack R, Busch R, Alt F, Beah ZM, Chong PW. Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation. Curr Ther Res Clin Exp. 2014 Jun 21;76:39-44. doi: 10.1016/j.curtheres.2014.02.001. eCollection 2014 Dec.