Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
NCT01407393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2013-10-08
Summary
Glucosanol™, the medical device to be investigated contains a proprietary plant extract that is a natural inhibitor of alpha-amylase and can reduce starch digestion.
The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.
Conditions
- Overweight and Obesity
Interventions
- DEVICE
-
Glucosanol
2 tablets 3x daily for 12 weeks
- DEVICE
-
Placebo
2 tablets 3x daily for 12 weeks
Sponsors & Collaborators
-
InQpharm Group
lead INDUSTRY
Principal Investigators
-
Barbara Grube, MD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2011-12-31
- Completion
- 2011-12-31
Countries
- Germany
Study Locations
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