Effect of Daily Glucomannan in Overweight Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Daily Glucomannan in Overweight Patients

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Glucomannan
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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 Currently enrolled in another weight loss study Currently enrolled in a weight loss program Active attempt to lose weight with diet and/or exercise within the last month 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucomannan<br>Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day. | Dietary Supplement: Glucomannan<br>* Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day. | Dietary Supplement: Placebo<br>* Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, Weight loss