Effect of Daily Glucomannan in Overweight Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥18 years old
- •Overweight (BMI ≥ 25 kg/m2)
排除标准
- •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
结局指标
主要结局
Weight
时间窗: 12 weeks
The primary outcome is the difference between weight at 12 weeks and the baseline weight.
次要结局
- Side Effects(Assessed at 2, 4, 8, and 12 week intervals)
研究者
Katherine Cochran
PGY1-Pharmacy Resident
ProMedica Health System