Safety and Efficacy of Litramine in Overweight and Obese Subjects

Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Weight Loss
• Intervention / Treatment: Device: Litramine; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Barbara Grube

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Device: Placebo; 2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Experimental: Litramine	Device: Litramine; 2 tablets 3 times daily (oral consumption, 30 minutes after meal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight loss (kg)	after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body fat content and fat free mass		after 12 weeks
hemogram, clinical chemistry parameter, and lipid profile		after 12 weeks
Proportion of subjects who lost at least 5% and 10% of baseline body weight		after 12 weeks
Subjects global feeling of satiety		every 4 weeks
Global evaluation of the incidence of food cravings		every 4 weeks
Changes in waist circumference (cm)		every 4 weeks
blood pressure		every 4 weeks
adverse events		every 4 weeks
Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)		after 8 and 12 weeks
Global evaluation of safety/tolerability	by subjects and investigators - based on rating scales	after 12 weeks

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Barbara Grube, MD

Publications and helpful links

General Publications

• 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. Erratum In: Obesity (Silver Spring). 2014 Oct;22(10):2274-5.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: November 2, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): October 13, 2011
• Last Update Submitted That Met QC Criteria: October 12, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: obesity; overweight; weight loss; satiety; body fat; waist circumference
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: INQ/K/00310