NCT01233349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

5 months

First QC Date

November 2, 2010

Last Update Submit

October 12, 2011

Conditions

OverweightObesityWeight Loss

Keywords

overweightobesityweight lossbody fatwaist circumferencesatiety

Outcome Measures

Primary Outcomes (1)

  • weight loss (kg)

    after 12 weeks

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Litramine

EXPERIMENTAL
Device: Litramine

Placebo

PLACEBO COMPARATOR
Device: Placebo

Interventions

LitramineDEVICE

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

Litramine
PlaceboDEVICE

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ≤ 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Grube

Berlin, Germany

Location

Related Publications (2)

  • 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.

    PMID: 24006357DERIVED

  • 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.

    PMID: 23505169DERIVED

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Barbara Grube, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

November 3, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

DE(1)