Effect of Daily Glucomannan in Overweight Patients

Obesity Clinical Trial

Official title:

Effect of Daily Glucomannan in Overweight Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01485718
• Other study ID #: 11-117
• Status: Unknown status
• Phase: Phase 4
• First received: November 26, 2011
• Last updated: December 9, 2011
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2011
• Source: ProMedica Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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
• Placebo
Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.

Locations

Country	Name	City	State
United States	W.W. Knight Family Practice Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ProMedica Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	The primary outcome is the difference between weight at 12 weeks and the baseline weight.	12 weeks
Secondary	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