Litramine in Weight Maintenance
Double-blind, Randomized, Placebo-controlled Clinical Investigation to Evaluate the Safety and Efficacy of Litramine in Maintaining Body Weight Loss in Overweight and Obese Subjects
1 other identifier
interventional
50
1 country
1
Brief Summary
The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2012
Shorter than P25 for phase_4
1 active site
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
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
April 3, 2015
CompletedJune 1, 2015
May 1, 2015
8 months
January 4, 2012
March 24, 2015
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Body Weight From Baseline to End of 24 Weeks
Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction
24 weeks
Secondary Outcomes (4)
Waist and Hip Circumference (cm)
24 weeks
Body Mass Index (kg/m^2)
24 weeks
Full Blood Count
24 weeks
Blood Pressure
24 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORIdentical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
Litramine
EXPERIMENTALFibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)
Interventions
Eligibility Criteria
You may qualify if:
- Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening
- BMI 25-35 before initial weight loss
- Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens
You may not qualify if:
- Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family)
- BMI \< 18.5
- Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InQpharm Grouplead
Study Sites (1)
Barbara Grube
Berlin, State of Berlin, 10709, Germany
Related Publications (1)
Grube B, Chong PW, Alt F, Uebelhack R. Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study. J Obes. 2015;2015:953138. doi: 10.1155/2015/953138. Epub 2015 Sep 7.
PMID: 26435849DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Felix Alt
- Organization
- Analyze & Realize
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2012
First Posted
January 6, 2012
Study Start
January 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
June 1, 2015
Results First Posted
April 3, 2015
Record last verified: 2015-05