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Litramine in Weight Maintenance

Primary Purpose

Weight Maintenance, Overweight, Obese

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Litramine

Placebo

About this trial

This is an interventional treatment trial for Weight Maintenance focused on measuring Weight maintenance, Overweight, Obese, Weight management

Eligibility Criteria

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

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

Sites / Locations

Barbara Grube

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Litramine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Waist and Hip Circumference (cm)

Changes from baseline to end of study

Body Mass Index (kg/m^2)

Changes from baseline to end of study

Full Blood Count

Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)

Blood Pressure

Measured in mm Hg

Full Information

NCT ID

NCT01505387

First Posted

January 4, 2012

Last Updated

May 13, 2015

Sponsor

InQpharm Group

1. Study Identification

Unique Protocol Identification Number

NCT01505387

Brief Title

Litramine in Weight Maintenance

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InQpharm Group

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Maintenance, Overweight, Obese

Keywords

Weight maintenance, Overweight, Obese, Weight management

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Litramine

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Litramine

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean Change in Body Weight From Baseline to End of 24 Weeks

Description

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

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Waist and Hip Circumference (cm)

Description

Changes from baseline to end of study

Time Frame

24 weeks

Title

Body Mass Index (kg/m^2)

Description

Changes from baseline to end of study

Time Frame

24 weeks

Title

Full Blood Count

Description

Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)

Time Frame

24 weeks

Title

Blood Pressure

Description

Measured in mm Hg

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Barbara Grube

City

Berlin

ZIP/Postal Code

10709

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26435849

Citation

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.

Results Reference

derived

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Litramine in Weight Maintenance

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