Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Tracking Information | |||||
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First Received Date ICMJE | June 30, 2011 | ||||
Last Updated Date | January 12, 2012 | ||||
Start Date ICMJE | May 2011 | ||||
Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] The primary endpoint of this randomized, double-blind, placebo-controlled bicen-tric study is to assess the weight loss effect of Glucosanol™ (kg), in combination with a weight loss program in overweight and obese subjects. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01407393 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects | ||||
Official Title ICMJE | Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects | ||||
Brief 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. |
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Detailed Description | Preparations that reduce absorption of calories from dietary carbohydrates could be decisively meaningful for the regulation of bodyweight or obesity. Hence, Glucosanol™ may be used as a tool for the treatment of obesity and weight management through reduced carbohydrate absorption. 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. The specific hypotheses to be accepted or rejected by statistical data from the clinical investigation are beneficial effects of the device on weight loss (kg) and body fat content. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Overweight and Obesity | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 124 | ||||
Completion Date | December 2011 | ||||
Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Germany | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01407393 | ||||
Other Study ID Numbers ICMJE | INQ/K/003411 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Barbara Grube, PI | ||||
Study Sponsor ICMJE | InQpharm Group | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | InQpharm Group | ||||
Verification Date | January 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |