NCT03741621

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 1992

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1992

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 1994

Completed
16.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 7, 2018

Last Update Submit

November 13, 2018

Conditions

LipidemiaHealthy

Keywords

dietary fibreViscositylipidsHealthy

Outcome Measures

Primary Outcomes (1)

  • change in LDL cholesterol

    change from baseline after 21 days, relative to control

Secondary Outcomes (5)

  • change in total cholesterol

    change from baseline after 21 days, relative to control

  • change in triglycerides

    change from baseline after 21 days, relative to control

  • change in HDL cholesterol

    change from baseline after 21 days, relative to control

  • change in apolipoprotein B

    change from baseline after 21 days, relative to control

  • change in apolipoprotein A-1

    change from baseline after 21 days, relative to control

Study Arms (3)

High Viscosity

EXPERIMENTAL

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

Medium Viscosity

EXPERIMENTAL

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

Low Viscosity

EXPERIMENTAL

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

Dietary Supplement: Wheat Bran

Interventions

Viscous Fibre BlendDIETARY_SUPPLEMENT

High viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company)

High Viscosity
PsylliumDIETARY_SUPPLEMENT

Bran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company)

Medium Viscosity
Wheat BranDIETARY_SUPPLEMENT

All Bran cereal (All Bran®; Kellogg Company)

Low Viscosity

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy individuals

You may not qualify if:

  • regular alcohol consumption
  • regular smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipidemias

Interventions

PsylliumDietary Fiber

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesDietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 15, 2018

Study Start

January 1, 1992

Primary Completion

January 1, 1994

Study Completion

July 1, 2010

Last Updated

November 15, 2018

Record last verified: 2018-11