Effect of Daily Glucomannan in Overweight Patients

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Overweight
• Intervention / Treatment: Dietary supplement: Glucomannan; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • W.W. Knight Family Practice Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

  1. Currently enrolled in another weight loss study
  2. Currently enrolled in a weight loss program
  3. Active attempt to lose weight with diet and/or exercise within the last month

  4. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glucomannan; Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day.	Dietary supplement: Glucomannan; Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks
Placebo Comparator: Placebo; Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.	Dietary supplement: Placebo; Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	The primary outcome is the difference between weight at 12 weeks and the baseline weight.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects	Patient reported side effects assessed at each patient visit. Specifically side effects related to gastrointestinal function.	Assessed at 2, 4, 8, and 12 week intervals

Collaborators and Investigators

• Sponsor: ProMedica Health System
• Investigators: Study Director: Steve Smith, MS, RPh, The Toledo Hospital; Study Chair: Ashley M Parrott, PharmD, The Toledo Hospital; Study Chair: Louito Edje, MD, The Toledo Hospital; Study Chair: Lindsey Bostelman, MD, The Toledo Hospital; Study Chair: David Knieriem, The Toledo Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: November 26, 2011
• First Submitted That Met QC Criteria: December 2, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 9, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight loss
• Additional Relevant MeSH Terms: Body Weight; Overweight; Gastrointestinal Agents; Cathartics; (1-6)-alpha-glucomannan
• Other Study ID Numbers: 11-117