Effect of Daily Glucomannan in Overweight Patients
Primary Purpose
Overweight, Obesity
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glucomannan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Obesity, Overweight, Weight loss
Eligibility Criteria
Inclusion Criteria:
- Patients ≥18 years old
- Overweight (BMI ≥ 25 kg/m2)
Exclusion Criteria:
- Pregnant or nursing women
- Women of childbearing age will be excluded unless they are on some form of contraception
Participation in any other formal or informal weight reduction program
- Currently enrolled in another weight loss study
- Currently enrolled in a weight loss program
- Active attempt to lose weight with diet and/or exercise within the last month
Currently on one of the following medications known to cause weight loss:
- Alli/Xenical(orlistat)
- Adipex-P (phentermine)
- Bontril (phendimetrazine)
- Dexoxyn (methamphetamine)
- Didrex (benzphetamine)
- Tenuate (diethylpropion)
- Meridia (sibutramine)
- Byetta (exenatide) or Victoza (liraglutide)
- Stimulants
- Recently (within the last three months) started on any medication that may cause weight gain
- A diagnosis of heart failure
- Structural abnormalities of the esophagus or gut
- Previous GI surgery for weight reduction
- Inflammatory bowel or irritable bowel disease
- A life expectancy of <6 months
- Allergy to glucomannan or any component of the placebo
Sites / Locations
- W.W. Knight Family Practice Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glucomannan
Placebo
Arm Description
Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day.
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Outcomes
Primary Outcome Measures
Weight
The primary outcome is the difference between weight at 12 weeks and the baseline weight.
Secondary Outcome Measures
Side Effects
Patient reported side effects assessed at each patient visit. Specifically side effects related to gastrointestinal function.
Full Information
NCT ID
NCT01485718
First Posted
November 26, 2011
Last Updated
December 9, 2011
Sponsor
ProMedica Health System
1. Study Identification
Unique Protocol Identification Number
NCT01485718
Brief Title
Effect of Daily Glucomannan in Overweight Patients
Official Title
Effect of Daily Glucomannan in Overweight Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ProMedica Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Glucomannan is a dietary supplement that has been marketed for weight loss. There is some research that supports this claim but more research is necessary. This is research study is being conducted to determine if the dietary supplement glucomannan is effective for weight loss in adults greater than 18 years of age who are overweight.
Participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times daily. The study will last for 12 weeks.
At the start of the study participants will be asked questions about current medications and diet/exercise regimen, a weight and height will be obtained, and they will be given a one-month's supply of study supplement. An investigator will call each participant after they have been taking the supplement for 2 weeks to ensure that the participant is tolerating the supplement and answer any questions. Throughout the study, participants will be required to follow-up with investigators in the office every 4 weeks (a total of 3 follow-up appointments). Every 4 weeks, the investigators will weigh participants, count the leftover capsules from the previous month, and ask about any adverse effects you may be experiencing. At the conclusion of the study, a final weight will be compared with the baseline weight to determine if the medication had an effect on weight loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Obesity, Overweight, Weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glucomannan
Arm Type
Active Comparator
Arm Description
Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucomannan
Intervention Description
Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Primary Outcome Measure Information:
Title
Weight
Description
The primary outcome is the difference between weight at 12 weeks and the baseline weight.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Side Effects
Description
Patient reported side effects assessed at each patient visit. Specifically side effects related to gastrointestinal function.
Time Frame
Assessed at 2, 4, 8, and 12 week intervals
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients ≥18 years old
Overweight (BMI ≥ 25 kg/m2)
Exclusion Criteria:
Pregnant or nursing women
Women of childbearing age will be excluded unless they are on some form of contraception
Participation in any other formal or informal weight reduction program
Currently enrolled in another weight loss study
Currently enrolled in a weight loss program
Active attempt to lose weight with diet and/or exercise within the last month
Currently on one of the following medications known to cause weight loss:
Alli/Xenical(orlistat)
Adipex-P (phentermine)
Bontril (phendimetrazine)
Dexoxyn (methamphetamine)
Didrex (benzphetamine)
Tenuate (diethylpropion)
Meridia (sibutramine)
Byetta (exenatide) or Victoza (liraglutide)
Stimulants
Recently (within the last three months) started on any medication that may cause weight gain
A diagnosis of heart failure
Structural abnormalities of the esophagus or gut
Previous GI surgery for weight reduction
Inflammatory bowel or irritable bowel disease
A life expectancy of <6 months
Allergy to glucomannan or any component of the placebo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Smith, MS, RPh
Organizational Affiliation
The Toledo Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ashley M Parrott, PharmD
Organizational Affiliation
The Toledo Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Louito Edje, MD
Organizational Affiliation
The Toledo Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lindsey Bostelman, MD
Organizational Affiliation
The Toledo Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Knieriem
Organizational Affiliation
The Toledo Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
W.W. Knight Family Practice Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Daily Glucomannan in Overweight Patients
We'll reach out to this number within 24 hrs