Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals

November 13, 2018 updated by: Unity Health Toronto

Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-healthy individuals

Exclusion Criteria:

  • regular alcohol consumption
  • regular smoking

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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High Viscosity
viscous fibre blend added to breakfast cereals consumed in the context of a typical North American diet for 3 weeks duration
Dietary supplement: Viscous Fibre Blend
High viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company)
EXPERIMENTAL: Medium Viscosity
Kellogg's Bran buds with psyllium breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration
Dietary supplement: Psyllium
Bran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company)
EXPERIMENTAL: Low Viscosity
Kellogg's All Bran breakfast cereal consumed in the context of a typical North American diet for 3 weeks duration
Dietary supplement: Wheat Bran
All Bran cereal (All Bran®; Kellogg Company)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in LDL cholesterol
Time Frame: change from baseline after 21 days, relative to control
change from baseline after 21 days, relative to control

Secondary Outcome Measures

Outcome Measure
Time Frame
change in total cholesterol
Time Frame: change from baseline after 21 days, relative to control
change from baseline after 21 days, relative to control
change in triglycerides
Time Frame: change from baseline after 21 days, relative to control
change from baseline after 21 days, relative to control
change in HDL cholesterol
Time Frame: change from baseline after 21 days, relative to control
change from baseline after 21 days, relative to control
change in apolipoprotein B
Time Frame: change from baseline after 21 days, relative to control
change from baseline after 21 days, relative to control
change in apolipoprotein A-1
Time Frame: change from baseline after 21 days, relative to control
change from baseline after 21 days, relative to control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

University of Toronto
Kellogg Company

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 (ACTUAL)

January 1, 1992

Primary Completion (ACTUAL)

January 1, 1994

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (ACTUAL)

November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • viscosity and cholesterol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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