Back to resultsEfficacy and Safety of Glucosanol in Maintaining Body Weight
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Glucosanol
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Weight maintenance, BMI, Body weight, Overweight, Obesity, Satiety
Eligibility Criteria
Inclusion Criteria:
- Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
- Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
- BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
- Expressed desire for weight maintenance
- Accustomed to 3 main meals per day
- Commitment to avoid the use of other weight loss products during study
- 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 (Phaseolus vulgaris or members of the Fabaceae family)
- History of diabetes mellitus • Fasting blood glucose more than 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 (more than 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 like 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 anti-diarrheals
- Pregnancy or nursing
- Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
- 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
- Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Sites / Locations
- Barbara Grube, MD
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Glucosanol
Arm Description
2 tablets 3 times a day
Outcomes
Primary Outcome Measures
Body weight
Measured in kg using a calibrated scale
Secondary Outcome Measures
Waist and hip circumference (cm)
Changes from baseline to end of study
Body mass index, BMI (kg/m2)
Changes from baseline to end of study
Body fat content and fat free mass
Changes from baseline to end of study
Effect on appetite, hunger and food cravings
The Control of Eating Questionnaire (COEQ) is used
Feeling of satiety
A 4-point categorical scale is used
Evaluation of the efficacy of Glucosanol by the subjects
A 4-point categorical scale is used
Full blood count
Done at baseline and end of study
Clinical chemistry parameter
Done at baseline and end of study
Blood pressure
Measured in mm Hg
Global evaluation of the safety of Glucosanol by the subjects
A 4-point categorical scale is used.
Global evaluation of the safety of Glucosanol by the investigators
A 4-point categorical scale is used
Occurrence of adverse events
All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01435278
Brief Title
Efficacy and Safety of Glucosanol in Maintaining Body Weight
Official Title
Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (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
To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Weight maintenance, BMI, Body weight, Overweight, Obesity, Satiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucosanol
Arm Type
Active Comparator
Arm Description
2 tablets 3 times a day
Intervention Type
Device
Intervention Name(s)
Glucosanol
Intervention Description
2 tablets taken 3 times a day.
Primary Outcome Measure Information:
Title
Body weight
Description
Measured in kg using a calibrated scale
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, BMI (kg/m2)
Description
Changes from baseline to end of study
Time Frame
24 weeks
Title
Body fat content and fat free mass
Description
Changes from baseline to end of study
Time Frame
24 weeks
Title
Effect on appetite, hunger and food cravings
Description
The Control of Eating Questionnaire (COEQ) is used
Time Frame
24 weeks
Title
Feeling of satiety
Description
A 4-point categorical scale is used
Time Frame
24 weeks
Title
Evaluation of the efficacy of Glucosanol by the subjects
Description
A 4-point categorical scale is used
Time Frame
24 weeks
Title
Full blood count
Description
Done at baseline and end of study
Time Frame
24 weeks
Title
Clinical chemistry parameter
Description
Done at baseline and end of study
Time Frame
24 weeks
Title
Blood pressure
Description
Measured in mm Hg
Time Frame
24 weeks
Title
Global evaluation of the safety of Glucosanol by the subjects
Description
A 4-point categorical scale is used.
Time Frame
24 weeks
Title
Global evaluation of the safety of Glucosanol by the investigators
Description
A 4-point categorical scale is used
Time Frame
24 weeks
Title
Occurrence of adverse events
Description
All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
Expressed desire for weight maintenance
Accustomed to 3 main meals per day
Commitment to avoid the use of other weight loss products during study
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 (Phaseolus vulgaris or members of the Fabaceae family)
History of diabetes mellitus • Fasting blood glucose more than 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 (more than 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 like 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 anti-diarrheals
Pregnancy or nursing
Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
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
Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
Facility Information:
Facility Name
Barbara Grube, MD
City
Berlin
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24006357
Citation
Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5. Erratum In: Obesity (Silver Spring). 2014 Oct;22(10):2274-5.
Results Reference
derived
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Efficacy and Safety of Glucosanol in Maintaining Body Weight
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