Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects

Launched by INQPHARM GROUP · Aug 1, 2011

Keywords

ClinConnect Summary

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 reject...

Gender

ALL

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