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The Effects of Glucomannan on Weight Loss

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ClinicalTrials.gov Identifier: NCT01709955
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : October 18, 2012
Sponsor:
Information provided by (Responsible Party):
Denise Holtzman MS DC, New York Chiropractic College

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Glucomannan Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Gucomannan Dietary Supplement: Glucomannan
750 MG of Glucomannan in capsule form
Placebo Comparator: Placebo pill Other: Placebo
750 mg of Cellulose powder in a capsule form


Outcome Measures
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Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 30 Days ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  1. Self-reported use of prescription medication other than hormonal birth control (such as medication for diabetes, hypertension hypothyroidism, heart disease, cancer, etc.)
  2. Pregnancy
  3. Age younger than 21 or older than 60 years of age.
  4. Screening for hypertension during the first laboratory visit that reveals a systole greater than 120 and a diastole greater than 90.
  5. BMI calculations based upon height and weight measurements at the first laboratory visit that reveal a BMI less than 25 or greater than 35.
  6. Self-reported iron-deficiency anemia, osteoporosis, and hypoglycemia.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Denise Holtzman MS DC, Associate professor, New York Chiropractic College
ClinicalTrials.gov Identifier: NCT01709955     History of Changes
Other Study ID Numbers: 10-13
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by Denise Holtzman MS DC, New York Chiropractic College:
Obesity
Overweight
Glucomannan

Additional relevant MeSH terms:
(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents