Status:
COMPLETED
Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Lead Sponsor:
InQpharm Group
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT01407393
Start Date
May 1 2011
End Date
December 1 2011
Last Update
October 8 2013
Active Locations (1)
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1
Barbara Grube
Berlin, Germany, 10709