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

June 30, 2011
October 7, 2013
May 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01407393 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects
Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overweight and Obesity
  • Device: Glucosanol
    2 tablets 3x daily for 12 weeks
    Other Name: Glucosanol
  • Device: Placebo
    2 tablets 3x daily for 12 weeks
    Other Name: Placebo
  • Experimental: Glucosanol
    Glucosanol
    Intervention: Device: Glucosanol
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Device: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01407393
INQ/K/003411
No
InQpharm Group
InQpharm Group
Not Provided
Principal Investigator: Barbara Grube, MD
InQpharm Group
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP