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Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals

Primary Purpose

Lipidemia, Healthy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Viscous Fibre Blend
Psyllium
Wheat Bran
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipidemia focused on measuring dietary fibre, Viscosity, lipids, Healthy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

-healthy individuals

Exclusion Criteria:

  • regular alcohol consumption
  • regular smoking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    High Viscosity

    Medium Viscosity

    Low Viscosity

    Arm Description

    viscous fibre blend added to breakfast cereals consumed in the context of a typical North American diet for 3 weeks duration

    Kellogg's Bran buds with psyllium breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration

    Kellogg's All Bran breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration

    Outcomes

    Primary Outcome Measures

    change in LDL cholesterol

    Secondary Outcome Measures

    change in total cholesterol
    change in triglycerides
    change in HDL cholesterol
    change in apolipoprotein B
    change in apolipoprotein A-1

    Full Information

    First Posted
    November 7, 2018
    Last Updated
    November 13, 2018
    Sponsor
    Unity Health Toronto
    Collaborators
    Kellogg Company, University of Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03741621
    Brief Title
    Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals
    Official Title
    Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1992 (Actual)
    Primary Completion Date
    January 1994 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Unity Health Toronto
    Collaborators
    Kellogg Company, University of Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in healthy individuals

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lipidemia, Healthy
    Keywords
    dietary fibre, Viscosity, lipids, Healthy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High Viscosity
    Arm Type
    Experimental
    Arm Description
    viscous fibre blend added to breakfast cereals consumed in the context of a typical North American diet for 3 weeks duration
    Arm Title
    Medium Viscosity
    Arm Type
    Experimental
    Arm Description
    Kellogg's Bran buds with psyllium breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration
    Arm Title
    Low Viscosity
    Arm Type
    Experimental
    Arm Description
    Kellogg's All Bran breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Viscous Fibre Blend
    Intervention Description
    High viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Psyllium
    Intervention Description
    Bran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Wheat Bran
    Intervention Description
    All Bran cereal (All Bran®; Kellogg Company)
    Primary Outcome Measure Information:
    Title
    change in LDL cholesterol
    Time Frame
    change from baseline after 21 days, relative to control
    Secondary Outcome Measure Information:
    Title
    change in total cholesterol
    Time Frame
    change from baseline after 21 days, relative to control
    Title
    change in triglycerides
    Time Frame
    change from baseline after 21 days, relative to control
    Title
    change in HDL cholesterol
    Time Frame
    change from baseline after 21 days, relative to control
    Title
    change in apolipoprotein B
    Time Frame
    change from baseline after 21 days, relative to control
    Title
    change in apolipoprotein A-1
    Time Frame
    change from baseline after 21 days, relative to control

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: -healthy individuals Exclusion Criteria: regular alcohol consumption regular smoking

    12. IPD Sharing Statement

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