NCT01435278

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

8 months

First QC Date

September 13, 2011

Last Update Submit

July 25, 2012

Conditions

OverweightObesity

Keywords

Weight maintenanceBMIBody weightOverweightObesitySatiety

Outcome Measures

Primary Outcomes (1)

  • Body weight

    Measured in kg using a calibrated scale

    24 weeks

Secondary Outcomes (12)

  • Waist and hip circumference (cm)

    24 weeks

  • Body mass index, BMI (kg/m2)

    24 weeks

  • Body fat content and fat free mass

    24 weeks

  • Effect on appetite, hunger and food cravings

    24 weeks

  • Feeling of satiety

    24 weeks

  • +7 more secondary outcomes

Study Arms (1)

Glucosanol

ACTIVE COMPARATOR

2 tablets 3 times a day

Device: Glucosanol

Interventions

GlucosanolDEVICE

2 tablets taken 3 times a day.

Glucosanol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Expressed desire for weight maintenance
  • Accustomed to 3 main meals per day
  • Commitment to avoid the use of other weight loss products during study
  • 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 (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. 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 (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.)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Grube, MD

Berlin, Germany

Location

Related Publications (1)

  • Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5.

    PMID: 24006357DERIVED

MeSH Terms

Conditions

OverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 16, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2012

Study Completion

July 1, 2012

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations

DE(1)