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

NCT01407393 | Completed Phase 4

• 1 other identifier: INQ/K/003411
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

overweight; obesity; weight loss; body fat; waste cirumference; satiety; appetite

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (10)

• Proportion body weight

  12 weeks

• waist circumference

  12 weeks

• hip circumference

  12 weeks

• waist-hip-ratio

  12 weeks

• BMI

  12 weeks

Study Arms (2)

Glucosanol

EXPERIMENTAL

Glucosanol

Device: Glucosanol

Placebo

PLACEBO COMPARATOR

Placebo

Device: Placebo

Interventions

Glucosanol DEVICE

2 tablets 3x daily for 12 weeks

Glucosanol

Placebo DEVICE

2 tablets 3x daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InQpharm Group: lead

Study Sites (1)

Barbara Grube

Berlin, 10709, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Barbara Grube, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: August 2, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

DE (1)