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Effect of Daily Glucomannan in Overweight Patients

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ClinicalTrials.gov Identifier: NCT01485718
Recruitment Status : Unknown
Verified December 2011 by Katherine Cochran, ProMedica Health System.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2011
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Katherine Cochran, ProMedica Health System

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.


Condition or disease Intervention/treatment Phase
Overweight Obesity Dietary Supplement: Glucomannan Dietary Supplement: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Daily Glucomannan in Overweight Patients
Study Start Date : October 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

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.



Primary Outcome Measures :
  1. Weight [ Time Frame: 12 weeks ]
    The primary outcome is the difference between weight at 12 weeks and the baseline weight.


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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Katherine Cochran, PGY1-Pharmacy Resident, ProMedica Health System
ClinicalTrials.gov Identifier: NCT01485718     History of Changes
Other Study ID Numbers: 11-117
First Posted: December 5, 2011    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011

Keywords provided by Katherine Cochran, ProMedica Health System:
Obesity
Overweight
Weight loss

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents