NCT00981981

Brief Summary

The purposes of this study were:

  1. 1.To determine if a breakfast cereal containing 3g of high molecular weight oat beta-glucan fiber would lower low-density lipoprotein (LDL) - cholesterol (the "bad" cholesterol) compared to a control cereal containing wheat fiber.
  2. 2.To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced when the molecular weight of the fiber was reduced.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
367

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2

Geographic Reach
3 countries

5 active sites

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

November 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

8 months

First QC Date

September 18, 2009

Last Update Submit

June 20, 2011

Conditions

Hypercholesterolemia

Keywords

humansrandomized clinical trialdietary fibernutritionbeta-glucanoatsLDL cholesterolcoronary heart disease

Outcome Measures

Primary Outcomes (2)

  • Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan

    4 weeks

  • Correlation between serum LDL-cholesterol lowering and log(MW*C)

    4 weeks

Secondary Outcomes (14)

  • Total cholesterol

    4 weeks

  • Serum triglycerides

    4 weeks

  • Serum HDL cholesterol

    4 weeks

  • Fasting serum glucose

    4 weeks

  • Serum aspartate transaminase

    4 weeks

  • +9 more secondary outcomes

Study Arms (5)

Control

PLACEBO COMPARATOR

Wheat bran cereal

Dietary Supplement: Wheat bran

3g high MW

ACTIVE COMPARATOR

Cereal containing 3g high molecular weight oat beta glucan

Dietary Supplement: 3g high MW

4g medium MW

ACTIVE COMPARATOR

Cereal containing 4g oat beta glucan with medium molecular weight

Dietary Supplement: 4g medium MW

3g medium MW

ACTIVE COMPARATOR

Cereal containing 3g oat beta glucan with medium molecular weight

Dietary Supplement: 3g medium MW

4g low MW

ACTIVE COMPARATOR

Cereal containing 4g oat beta glucan with low molecular weight

Dietary Supplement: 4g low MW

Interventions

Wheat branDIETARY_SUPPLEMENT

21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.

Control
3g high MWDIETARY_SUPPLEMENT

20.2 grams per day of ready to eat cereal containing 6g total dietary fiber and 3g oat beta glucan with high molecular weight

3g high MW
4g medium MWDIETARY_SUPPLEMENT

28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight

4g medium MW
3g medium MWDIETARY_SUPPLEMENT

21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight

3g medium MW
4g low MWDIETARY_SUPPLEMENT

28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight

4g low MW

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index 18.5 to 40.0 kg/m\^2
  • no intention to lose or gain weight
  • fasting total cholesterol 5.0 to 8.0 mmol/L
  • fasting LDL cholesterol 3.0 to 5.0 mmol/L
  • consuming diet containing \<15% energy from saturated fat

You may not qualify if:

  • use of any cholesterol-lowering drug, herbal or nutritional supplement
  • regular consumption of oatmeal, oat bran or psyllium - containing cereals
  • fasting serum triglycerides \>4.0mmol/L
  • serum aspartate transaminase \>1.5 times upper limit of normal
  • serum urea or creatinine \>1.8 times upper limit of normal
  • presence of diabetes or fasting glucose \>6.9mmol/L
  • presence or recent major surgical or medical event
  • allergy to wheat or oats
  • presence of condition or drug which alters digestion or absorption of foods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney

Sydney, New South Wales, 2006, Australia

Location

Human Nutraceutical Research Unit, Department of Human Health and Nutritional Sciences, University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Glycemic Index Laboratories, Inc.

Toronto, Ontario, M5C 2X3, Canada

Location

Nutraceuticals and Functional Foods Institute, Faculte des science de l'agriculture et de l'alimentation, Universite Laval

Laval, Quebec, Canada

Location

Reading Scientific Services, Ltd (RSSL)

Reading, Berkshire, RG6 6LA, United Kingdom

Location

Related Publications (3)

  • Wolever TM, Tosh SM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Thomson BA, Duss R, Wood PJ. Physicochemical properties of oat beta-glucan influence its ability to reduce serum LDL cholesterol in humans: a randomized clinical trial. Am J Clin Nutr. 2010 Oct;92(4):723-32. doi: 10.3945/ajcn.2010.29174. Epub 2010 Jul 21.

    PMID: 20660224RESULT

  • Tosh SM, Brummer Y, Miller SS, Regand A, Defelice C, Duss R, Wolever TM, Wood PJ. Processing affects the physicochemical properties of beta-glucan in oat bran cereal. J Agric Food Chem. 2010 Jul 14;58(13):7723-30. doi: 10.1021/jf904553u.

    PMID: 20527967RESULT

  • Wolever TM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Tosh SM, Duss R. Bioactive oat beta-glucan reduces LDL cholesterol in Caucasians and non-Caucasians. Nutr J. 2011 Nov 25;10:130. doi: 10.1186/1475-2891-10-130.

    PMID: 22118569DERIVED

MeSH Terms

Conditions

HypercholesterolemiaCoronary Disease

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Thomas MS Wolever, MD, PhD

    Glycemic Index Laboratories, Inc

    PRINCIPAL INVESTIGATOR

  • Peter J Wood, PhD

    Agriculture and Agri-Food Canada

    STUDY DIRECTOR

  • Susan M Tosh, PhD

    Agriculture and Agri-Food Canada

    STUDY DIRECTOR

  • Alison L Gibbs, PhD

    Department of Statistics, University of Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 22, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

June 21, 2011

Record last verified: 2011-06

Locations

AU(1)GB(1)CA(3)