NCT01709955

Brief Summary

The purpose of this study is to determine if the herb, Glucomannan, is an effective non-pharmacological appetite suppressant for overweight or Class I obese patients. The study design will not include any other lifestyle changes which enhance weight loss in order to completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_1 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

5 months

First QC Date

October 16, 2012

Last Update Submit

October 17, 2012

Conditions

Obesity

Keywords

ObesityOverweightGlucomannan

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    30 Days

Study Arms (2)

Gucomannan

EXPERIMENTAL
Dietary Supplement: Glucomannan

Placebo pill

PLACEBO COMPARATOR
Other: Placebo

Interventions

GlucomannanDIETARY_SUPPLEMENT

750 MG of Glucomannan in capsule form

Gucomannan
PlaceboOTHER

750 mg of Cellulose powder in a capsule form

Placebo pill

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must be able to swallow the capsule whole with water.

You may not qualify if:

  • Self-reported use of prescription medication other than hormonal birth control (such as medication for diabetes, hypertension hypothyroidism, heart disease, cancer, etc.)
  • Pregnancy
  • Age younger than 21 or older than 60 years of age.
  • Screening for hypertension during the first laboratory visit that reveals a systole greater than 120 and a diastole greater than 90.
  • BMI calculations based upon height and weight measurements at the first laboratory visit that reveal a BMI less than 25 or greater than 35.
  • Self-reported iron-deficiency anemia, osteoporosis, and hypoglycemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityOverweight

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 18, 2012

Study Start

February 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 18, 2012

Record last verified: 2012-10