Effect of Daily Glucomannan in Overweight Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by ProMedica Health System.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Katherine Cochran, ProMedica Health System
ClinicalTrials.gov Identifier:
NCT01485718
First received: November 26, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Dietary Supplement: Glucomannan
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Daily Glucomannan in Overweight Patients

Resource links provided by NLM:


Further study details as provided by ProMedica Health System:

Primary Outcome Measures:
  • Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary outcome is the difference between weight at 12 weeks and the baseline weight.


Secondary Outcome Measures:
  • Side Effects [ Time Frame: Assessed at 2, 4, 8, and 12 week intervals ] [ Designated as safety issue: Yes ]
    Patient reported side effects assessed at each patient visit. Specifically side effects related to gastrointestinal function.


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

    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
  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: NCT01485718

Locations
United States, Ohio
W.W. Knight Family Practice Center
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Katherine Cochran, PGY1-Pharmacy Resident, ProMedica Health System
ClinicalTrials.gov Identifier: NCT01485718     History of Changes
Other Study ID Numbers: 11-117
Study First Received: November 26, 2011
Last Updated: December 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by ProMedica Health System:
Obesity
Overweight
Weight loss

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014