- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01709955
The Effects of Glucomannan on Weight Loss
October 17, 2012 updated by: Denise Holtzman MS DC, Northeast College of Health Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:Subjects will be recruited based upon the category of them wanting to lose 50 pounds.
Subjects must be able to swallow the capsule whole with water.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo pill
|
750 mg of Cellulose powder in a capsule form
|
EXPERIMENTAL: Gucomannan
|
750 MG of Glucomannan in capsule form
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight Loss
Time Frame: 30 Days
|
30 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (ACTUAL)
July 1, 2011
Study Completion (ACTUAL)
July 1, 2011
Study Registration Dates
First Submitted
October 16, 2012
First Submitted That Met QC Criteria
October 17, 2012
First Posted (ESTIMATE)
October 18, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
October 18, 2012
Last Update Submitted That Met QC Criteria
October 17, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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