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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01407393
First received: June 30, 2011
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Overweight and Obesity
Device: Glucosanol
Device: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in waist circumference

  • hip circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in hip circumference

  • waist-hip-ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in waist-hip-ratio

  • BMI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in BMI

  • body fat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in body fat (% and kg) and fat free mass (kg)

  • hunger [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire

  • Global evaluation of feeling of satiety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This parameter will be assessed by a 4 points categorical scale

  • Global evaluation of the efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This parameter will be assessed by a 4 points categorical scale

  • Global evaluation of safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    This will be assessed by both investigators and subjects by a 4 points categorical scale.


Enrollment: 124
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucosanol
Glucosanol
Device: Glucosanol
2 tablets 3x daily for 12 weeks
Other Name: Glucosanol
Placebo Comparator: Placebo
Placebo
Device: Placebo
2 tablets 3x daily for 12 weeks
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407393

Locations
Germany
Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Barbara Grube, MD
  More Information

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01407393     History of Changes
Other Study ID Numbers: INQ/K/003411
Study First Received: June 30, 2011
Last Updated: October 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by InQpharm Group:
overweight
obesity
weight loss
body fat
waste cirumference
satiety
appetite

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Overnutrition
Nutrition Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014