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The Effects of Glucomannan on Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Glucomannan
Placebo
Sponsored by
Northeast College of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Glucomannan

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Gucomannan

    Placebo pill

    Arm Description

    Outcomes

    Primary Outcome Measures

    Weight Loss

    Secondary Outcome Measures

    Full Information

    First Posted
    October 16, 2012
    Last Updated
    October 17, 2012
    Sponsor
    Northeast College of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01709955
    Brief Title
    The Effects of Glucomannan on Weight Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northeast College of Health Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Obesity, Overweight, Glucomannan

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gucomannan
    Arm Type
    Experimental
    Arm Title
    Placebo pill
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Glucomannan
    Intervention Description
    750 MG of Glucomannan in capsule form
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    750 mg of Cellulose powder in a capsule form
    Primary Outcome Measure Information:
    Title
    Weight Loss
    Time Frame
    30 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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: 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.

    12. IPD Sharing Statement

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    The Effects of Glucomannan on Weight Loss

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