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Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals

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ClinicalTrials.gov Identifier: NCT03741621
Recruitment Status : Completed
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
Kellogg Company
University of Toronto
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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

Condition or disease Intervention/treatment Phase
Lipidemia Healthy Dietary Supplement: Viscous Fibre Blend Dietary Supplement: Psyllium Dietary Supplement: Wheat Bran Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals
Actual Study Start Date : January 1992
Actual Primary Completion Date : January 1994
Actual Study Completion Date : July 2010


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)




Primary Outcome Measures :
  1. change in LDL cholesterol [ Time Frame: change from baseline after 21 days, relative to control ]

Secondary Outcome Measures :
  1. change in total cholesterol [ Time Frame: change from baseline after 21 days, relative to control ]
  2. change in triglycerides [ Time Frame: change from baseline after 21 days, relative to control ]
  3. change in HDL cholesterol [ Time Frame: change from baseline after 21 days, relative to control ]
  4. change in apolipoprotein B [ Time Frame: change from baseline after 21 days, relative to control ]
  5. change in apolipoprotein A-1 [ Time Frame: change from baseline after 21 days, relative to control ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-healthy individuals

Exclusion Criteria:

  • regular alcohol consumption
  • regular smoking

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03741621     History of Changes
Other Study ID Numbers: viscosity and cholesterol
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Michael's Hospital, Toronto:
dietary fibre
Viscosity
lipids
Healthy

Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals