Litramine in Weight Maintenance

NCT ID: NCT01505387

Last Updated: 2015-06-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Maintenance Overweight Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)

Litramine

Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)

Group Type EXPERIMENTAL

Litramine

Intervention Type DIETARY_SUPPLEMENT

Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)

Interventions

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Litramine

Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InQpharm Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barbara Grube

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26435849 (View on PubMed)

Other Identifiers

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INQ/024511

Identifier Type: -

Identifier Source: org_study_id

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