Effect of Daily Glucomannan in Overweight Patients

NCT01485718 | Unknown Phase 4

• 1 other identifier: 11-117
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Obesity; Overweight; Weight loss

Outcome Measures

Primary Outcomes (1)

• Weight

  The primary outcome is the difference between weight at 12 weeks and the baseline weight.

  12 weeks

Secondary Outcomes (1)

• Side Effects

  Assessed at 2, 4, 8, and 12 week intervals

Study Arms (2)

Glucomannan

ACTIVE COMPARATOR

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

Dietary Supplement: Glucomannan

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Glucomannan DIETARY_SUPPLEMENT

Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks

Glucomannan

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years old
• Overweight (BMI ≥ 25 kg/m2)

You may not qualify if:

• 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)

Sponsors & Collaborators

• ProMedica Health System: lead

Study Sites (1)

W.W. Knight Family Practice Center

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Steve Smith, MS, RPh

  The Toledo Hospital

  STUDY DIRECTOR

• Ashley M Parrott, PharmD

  The Toledo Hospital

  STUDY CHAIR

• Louito Edje, MD

  The Toledo Hospital

  STUDY CHAIR

• Lindsey Bostelman, MD

  The Toledo Hospital

  STUDY CHAIR

• David Knieriem

  The Toledo Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGY1-Pharmacy Resident

Study Record Dates

• First Submitted: November 26, 2011
• First Posted: December 5, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

US (1)