Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2011-10-31
2012-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Glucomannan
Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day.
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
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Placebo
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Interventions
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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
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Eligibility Criteria
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Inclusion Criteria
* Overweight (BMI ≥ 25 kg/m2)
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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ProMedica Health System
OTHER
Responsible Party
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Katherine Cochran
PGY1-Pharmacy Resident
Principal Investigators
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Steve Smith, MS, RPh
Role: STUDY_DIRECTOR
The Toledo Hospital
Ashley M Parrott, PharmD
Role: STUDY_CHAIR
The Toledo Hospital
Louito Edje, MD
Role: STUDY_CHAIR
The Toledo Hospital
Lindsey Bostelman, MD
Role: STUDY_CHAIR
The Toledo Hospital
David Knieriem
Role: STUDY_CHAIR
The Toledo Hospital
Locations
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W.W. Knight Family Practice Center
Toledo, Ohio, United States
Countries
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Other Identifiers
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11-117
Identifier Type: -
Identifier Source: org_study_id