Clinical trial NCT01233349: Safety and Efficacy of Litramine in Overweight and Obese Subjects
Official title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Weight Loss
Keywords: overweight
obesity
weight loss
body fat
waist circumference
satiety
Lead sponsor: InQpharm Group
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat.

Therefore, the rationale for this study is to confirm that Litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.


Eligibility criteria: Inclusion Criteria:

* 25 ≤ BMI ≤ 35
* Expressed desire for weight loss
* Accustomed to 3 main meals/day
* Consistent and stable body weight 3 months prior to study enrolment
* Commitment to avoid the use of other weight loss products during study
* Commitment to adhere to diet recommendation
* Females' agreement to use appropriate birth control methods during the active study period
* 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
* Presence of any active gastrointestinal disease
* Malabsorption disorders (e.g. Coeliac disease)
* Pancreatitis
* Stenosis in the GI tract
* Bariatric surgery
* Abdominal surgery within the last 6 months prior to the study
* History of eating disorders like bulimia, anorexia nervosa
* History of renal disease
* History of nephrolithiasis
* History of cardiac diseases
* Osteoporosis
* Other serious organ or systemic diseases such as cancer, HIV, or diabetes mellitus
* Any medication that could influence GI functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before study start)
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity (e.g., Orlistat, other fatbinder, fatburner, satiety products etc.)
* More than 3 hours serious sport activity per week
* History of abuse of drugs, alcohol or medication
* Smoking cessation within the 6 months prior to this study
* Inability to comply due to language difficulties
* Participation in similar studies or weight loss programs within the 6 months prior to this study
* Participation in other studies within the last 4 weeks

Primary outcomes:
measure: weight loss (kg)
timeFrame: after 12 weeks
Secondary outcomes:
measure: body fat content and fat free mass
timeFrame: after 12 weeks
measure: hemogram, clinical chemistry parameter, and lipid profile
timeFrame: after 12 weeks
measure: Proportion of subjects who lost at least 5% and 10% of baseline body weight
timeFrame: after 12 weeks
measure: Subjects global feeling of satiety
timeFrame: every 4 weeks
measure: Global evaluation of the incidence of food cravings
timeFrame: every 4 weeks
measure: Changes in waist circumference (cm)
timeFrame: every 4 weeks
measure: blood pressure
timeFrame: every 4 weeks
measure: adverse events
timeFrame: every 4 weeks
measure: Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)
timeFrame: after 8 and 12 weeks
measure: Global evaluation of safety/tolerability
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Barbara Grube
Study officials:
name: Barbara Grube, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5.
citation: Grube B, Chong PW, Lau KZ, Orzechowski HD. A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study. Obesity (Silver Spring). 2013 Jan;21(1):58-64. doi: 10.1002/oby.20244.