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The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids

Primary Purpose

Obesity, Overweight, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Irvingia/cissus combo
Sponsored by
Gateway Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Antiobesity, Weight loss

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI>26kg/m2

Exclusion Criteria:

  • Diabetics
  • Pregnant and lactating
  • Subjects on any other weight loss program
  • Following any specific low calorie diet

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Active Comparator

    Arm Label

    1

    Arm Description

    Comparison of actives for synergy

    Outcomes

    Primary Outcome Measures

    Weight change

    Secondary Outcome Measures

    Blood lipids Body fat Fasting blood glucose

    Full Information

    First Posted
    September 6, 2007
    Last Updated
    September 6, 2007
    Sponsor
    Gateway Health Alliance
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00526682
    Brief Title
    The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids
    Official Title
    The Effect of Combining Cissus Quadrangularis and Irvingia Gabonensis on Obesity and Obesity Related Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gateway Health Alliance

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight management and related conditions. This study set out to investigate if a combination of the two could have additional benefits to overweight and obese people.
    Detailed Description
    To assess and compare the effects of administration of Cissus quadrangularis (Linn) and a Cissus quadrangularis /Irvingia gabonensis combination on body weight blood pressure, fasting blood glucose, plasma total and LDL cholesterol in 72 overweight and obese subjects. The study was a 10 week randomized, double-blind, placebo-controlled design, involving 72 obese or overweight participants. Participants were randomly divided into three groups (24 participants/ group): Group 1 - Placebo; Group 2 - Cissus quadrangularis (CQ); Group 3 - Cissus quadrangularis and Irvingia gabonensis (CQ-IG). The placebo (250mg) or active formulations ((150 mg CQ and 250 mg CQ-IG) were administered twice daily before meals. Weight as well as fasting blood was taken at baseline, and at 4, 8 and 10 weeks. No major dietary changes or exercises were suggested during the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Overweight, Dyslipidemia
    Keywords
    Antiobesity, Weight loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Comparison of actives for synergy
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Irvingia/cissus combo
    Other Intervention Name(s)
    Irvingia cissus combo
    Primary Outcome Measure Information:
    Title
    Weight change
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Blood lipids Body fat Fasting blood glucose
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI>26kg/m2 Exclusion Criteria: Diabetics Pregnant and lactating Subjects on any other weight loss program Following any specific low calorie diet
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julius E OBEN, PhD
    Organizational Affiliation
    University of Yaounde 1
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids

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