Back to resultsSafety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Glucosanol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring overweight, obesity, weight loss, body fat, waste cirumference, satiety, appetite
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 60 years
- BMI between 25 and 35
- Expressed desire for weight loss
- Accustomed to 3 main meals/day
- Consistent and stable body weight 3 months prior to study enrolment
- Commitment to avoid the use of other weight loss products during study
- Commitment to adhere to diet recommendation
- Females' agreement to use appropriate birth control methods during the active study period
- Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion Criteria:
- Known sensitivity to the ingredients of the device
- History of Diabetes mellitus
- Fasting blood glucose >7 mmol/L
- History or clinical signs of endocrine disorders which may influence body weight (e.g., Cushing's disease, thyroid gland disorders)
- Clinically relevant excursions of safety parameter
- Current use of anti-depressants
- Presence of acute or chronic gastrointestinal disease (e.g., IBD, coeliac disease. pancreatitis)
- Uncontrolled hypertension (>160/110 mm Hg)
- Stenosis in the GI tract
- Bariatric surgery
- Abdominal surgery within the last 6 months prior to enrollment
- History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
- Other serious organ or systemic diseases such as cancer
- Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or antidiarrheals (e.g., loperamide; must have stopped 1 months before study start)
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity
- More than 3 hours strenuous sport activity per week
- History of abuse of drugs, alcohol or medication
- Smoking cessation within 6 months prior to enrolment
- Inability to comply due to language difficulties
- Participation in similar studies or weight loss programs within 3 months prior to enrolment
- Participation in other studies within 4 weeks prior to enrollment
Sites / Locations
- Barbara Grube
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Glucosanol
Placebo
Arm Description
Glucosanol
Placebo
Outcomes
Primary Outcome Measures
weight loss
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.
Secondary Outcome Measures
Proportion body weight
To assess the efficacy of Glucosanol™ to increase the proportions of subjects who lose at least 3% and 5% of baseline body weight
waist circumference
Changes in waist circumference
hip circumference
Changes in hip circumference
waist-hip-ratio
Changes in waist-hip-ratio
BMI
Changes in BMI
body fat
Changes in body fat (% and kg) and fat free mass (kg)
hunger
Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire
Global evaluation of feeling of satiety
This parameter will be assessed by a 4 points categorical scale
Global evaluation of the efficacy
This parameter will be assessed by a 4 points categorical scale
Global evaluation of safety
This will be assessed by both investigators and subjects by a 4 points categorical scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01407393
Brief Title
Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Official Title
Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InQpharm Group
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
overweight, obesity, weight loss, body fat, waste cirumference, satiety, appetite
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucosanol
Arm Type
Experimental
Arm Description
Glucosanol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Device
Intervention Name(s)
Glucosanol
Intervention Description
2 tablets 3x daily for 12 weeks
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
2 tablets 3x daily for 12 weeks
Primary Outcome Measure Information:
Title
weight loss
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion body weight
Description
To assess the efficacy of Glucosanol™ to increase the proportions of subjects who lose at least 3% and 5% of baseline body weight
Time Frame
12 weeks
Title
waist circumference
Description
Changes in waist circumference
Time Frame
12 weeks
Title
hip circumference
Description
Changes in hip circumference
Time Frame
12 weeks
Title
waist-hip-ratio
Description
Changes in waist-hip-ratio
Time Frame
12 weeks
Title
BMI
Description
Changes in BMI
Time Frame
12 weeks
Title
body fat
Description
Changes in body fat (% and kg) and fat free mass (kg)
Time Frame
12 weeks
Title
hunger
Description
Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire
Time Frame
12 weeks
Title
Global evaluation of feeling of satiety
Description
This parameter will be assessed by a 4 points categorical scale
Time Frame
12 weeks
Title
Global evaluation of the efficacy
Description
This parameter will be assessed by a 4 points categorical scale
Time Frame
12 weeks
Title
Global evaluation of safety
Description
This will be assessed by both investigators and subjects by a 4 points categorical scale.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 to 60 years
BMI between 25 and 35
Expressed desire for weight loss
Accustomed to 3 main meals/day
Consistent and stable body weight 3 months prior to study enrolment
Commitment to avoid the use of other weight loss products during study
Commitment to adhere to diet recommendation
Females' agreement to use appropriate birth control methods during the active study period
Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion Criteria:
Known sensitivity to the ingredients of the device
History of Diabetes mellitus
Fasting blood glucose >7 mmol/L
History or clinical signs of endocrine disorders which may influence body weight (e.g., Cushing's disease, thyroid gland disorders)
Clinically relevant excursions of safety parameter
Current use of anti-depressants
Presence of acute or chronic gastrointestinal disease (e.g., IBD, coeliac disease. pancreatitis)
Uncontrolled hypertension (>160/110 mm Hg)
Stenosis in the GI tract
Bariatric surgery
Abdominal surgery within the last 6 months prior to enrollment
History of eating disorders such as bulimia, anorexia nervosa within the past 12 months
Other serious organ or systemic diseases such as cancer
Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or antidiarrheals (e.g., loperamide; must have stopped 1 months before study start)
Pregnancy or nursing
Any medication or use of products for the treatment of obesity
More than 3 hours strenuous sport activity per week
History of abuse of drugs, alcohol or medication
Smoking cessation within 6 months prior to enrolment
Inability to comply due to language difficulties
Participation in similar studies or weight loss programs within 3 months prior to enrolment
Participation in other studies within 4 weeks prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Grube, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Grube
City
Berlin
ZIP/Postal Code
10709
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
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