Effect of Daily Glucomannan in Overweight Patients
NCT01485718 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2011-12-13
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.
Conditions
Interventions
- 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
- DIETARY_SUPPLEMENT
-
Placebo
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Sponsors & Collaborators
-
ProMedica Health System
lead OTHER
Principal Investigators
-
Steve Smith, MS, RPh · The Toledo Hospital
-
Ashley M Parrott, PharmD · The Toledo Hospital
-
Louito Edje, MD · The Toledo Hospital
-
Lindsey Bostelman, MD · The Toledo Hospital
-
David Knieriem · The Toledo Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2012-03-31
- Completion
- 2012-03-31
Countries
- United States
Study Locations
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