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Safety and Efficacy of Litramine in Overweight and Obese Subjects

Primary Purpose

Overweight, Obesity, Weight Loss

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Litramine
Placebo
Sponsored by
InQpharm Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, weight loss, body fat, waist circumference, satiety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Barbara Grube

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Litramine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

weight loss (kg)

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2010
Last Updated
October 12, 2011
Sponsor
InQpharm Group
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1. Study Identification

Unique Protocol Identification Number
NCT01233349
Brief Title
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Weight Loss
Keywords
overweight, obesity, weight loss, body fat, waist circumference, satiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Litramine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Litramine
Intervention Description
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Primary Outcome Measure Information:
Title
weight loss (kg)
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
body fat content and fat free mass
Time Frame
after 12 weeks
Title
hemogram, clinical chemistry parameter, and lipid profile
Time Frame
after 12 weeks
Title
Proportion of subjects who lost at least 5% and 10% of baseline body weight
Time Frame
after 12 weeks
Title
Subjects global feeling of satiety
Time Frame
every 4 weeks
Title
Global evaluation of the incidence of food cravings
Time Frame
every 4 weeks
Title
Changes in waist circumference (cm)
Time Frame
every 4 weeks
Title
blood pressure
Time Frame
every 4 weeks
Title
adverse events
Time Frame
every 4 weeks
Title
Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)
Time Frame
after 8 and 12 weeks
Title
Global evaluation of safety/tolerability
Description
by subjects and investigators - based on rating scales
Time Frame
after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Grube, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Grube
City
Berlin
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24006357
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. Erratum In: Obesity (Silver Spring). 2014 Oct;22(10):2274-5.
Results Reference
derived
PubMed Identifier
23505169
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.
Results Reference
derived

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Safety and Efficacy of Litramine in Overweight and Obese Subjects

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