Efficacy and Safety of Glucosanol in Maintaining Body Weight

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01435278
First received: September 13, 2011
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.


Condition Intervention Phase
Overweight
Obesity
Device: Glucosanol
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects

Resource links provided by NLM:


Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Measured in kg using a calibrated scale


Secondary Outcome Measures:
  • Waist and hip circumference (cm) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from baseline to end of study

  • Body mass index, BMI (kg/m2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from baseline to end of study

  • Body fat content and fat free mass [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from baseline to end of study

  • Effect on appetite, hunger and food cravings [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The Control of Eating Questionnaire (COEQ) is used

  • Feeling of satiety [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    A 4-point categorical scale is used

  • Evaluation of the efficacy of Glucosanol by the subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    A 4-point categorical scale is used

  • Full blood count [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Done at baseline and end of study

  • Clinical chemistry parameter [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Done at baseline and end of study

  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Measured in mm Hg

  • Global evaluation of the safety of Glucosanol by the subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    A 4-point categorical scale is used.

  • Global evaluation of the safety of Glucosanol by the investigators [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    A 4-point categorical scale is used

  • Occurrence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms


Enrollment: 51
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glucosanol
2 tablets 3 times a day
Device: Glucosanol
2 tablets taken 3 times a day.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight
  • Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study
  • BMI between 25-35 at the time of inclusion into the INQ/K/003411 study
  • Expressed desire for weight maintenance
  • Accustomed to 3 main meals per day
  • Commitment to avoid the use of other weight loss products during study
  • Femalesʼ 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 (Phaseolus vulgaris or members of the Fabaceae family)
  • History of diabetes mellitus • Fasting blood glucose more than 7 mmol/L
  • History or clinical signs of endocrine disorders which may influence body weight (e.g. Cushingʼs 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 (more than 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 like 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 anti-diarrheals
  • Pregnancy or nursing
  • Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.)
  • 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
  • Presence of other factor(s) that, in the investigatorʼs judgement, should preclude subject participation
  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: NCT01435278

Locations
Germany
Barbara Grube, MD
Berlin, Germany
Sponsors and Collaborators
InQpharm Group
  More Information

No publications provided by InQpharm Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01435278     History of Changes
Other Study ID Numbers: INQ/017011
Study First Received: September 13, 2011
Last Updated: July 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by InQpharm Group:
Weight maintenance
BMI
Body weight
Overweight
Obesity
Satiety

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

ClinicalTrials.gov processed this record on July 22, 2014