Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, Weight loss
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.
Interventions
DIETARY_SUPPLEMENTGlucomannan
Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
Sponsors
ProMedica Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 12 weeks | The primary outcome is the difference between weight at 12 weeks and the baseline weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects | 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. |
Countries
United States
Outcome results
None listed