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HypercholesterolemiaPhase 2BluebirdNCT00981981

Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol

A Phase 2 study testing Wheat bran, 3g high MW and 4g medium MW in people with Hypercholesterolemia, run by Glycemic Index Laboratories, Inc at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this study were: 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. Read more about this study

Who is it for?
Ages 35 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hypercholesterolemia
What is being tested?
Wheat bran, 3g high MW and 4g medium MW
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
367 participants
Where
5 sitesin 3 countries
Study dates
Nov 2008to Aug 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

Canada3 sites

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

    Guelph, Ontario, N1G 2W1

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

    Laval, Quebec

  • Glycemic Index Laboratories, Inc.

    Toronto, Ontario, M5C 2X3

Other trials in Canada

Australia1 site

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

    Sydney, New South Wales, 2006

Other trials in Australia

United Kingdom1 site

  • Reading Scientific Services, Ltd (RSSL)

    Reading, Berkshire, RG6 6LA

Other trials in United Kingdom

About this study

Official title: Effect of Varying Dose and Molecular Weight on the Serum LDL-cholesterol-lowering Properties of Oat β-glucan

The purposes of this study were:

  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. To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced when the molecular weight of the fiber was reduced.
Read the detailed description

The FDA allows a health claim that oat products may reduce the risk of heart disease, based on meta-analyses showing a cholesterol-lowering effect of oat beta-glucan, if the product delivers at least a 3g daily dose of oat beta-glucan. However, not all studies have demonstrated a lowering of oat products. This may be due to variable bioactivity of the beta-glucan in the oat products. The bioactivity of oat beta-glucan is believed to depend upon its viscosity in the gut. Factors influencing viscosity include the molecular weight (MW) of the beta-glucan molecule and the amount of soluble beta-glucan in the product, which, in turn determines its concentration (C) in solution. In finished food products both MW and C can be modified by beta-glucanase enzymes present in other ingredients in the food (eg. wheat flour), processing (eg. extrusion) and storage (eg. freezing of moist products such as muffins). The effect of altering the MW and solubility of beta-glucan in foods on glycemic responses has been shown, but a role for MW and C in cholesterol lowering has not been established.

To address this issue, this study was designed with 2 primary objectives:

  1. An extruded oat cereal containing 3g high-molecular weight oat β-glucan daily will reduce LDL cholesterol compared to a control wheat bran cereal.
  2. A significant correlation exists between LDL cholesterol and log(C×MW), where C is the amount of soluble β-glucan in the daily dose of cereal and MW is the molecular weight of the β-glucan in the cereal.
Being tested
Wheat bran, 3g high MW, 4g medium MW, 3g medium MW, 4g low MW
Keywords
humans, randomized clinical trial, dietary fiber, nutrition, beta-glucan, oats, LDL cholesterol, coronary heart disease
Medical subject headings
Hypercholesterolemia, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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

  • 4g medium MWDietary supplement

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

  • 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

  • 4g low MWDietary supplement

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

Study groups in NCT00981981
Study groupRoleWhat they receive
ControlPlacebo comparatorWheat bran cereal
Receives: Dietary Supplement: Wheat bran
3g high MWActive comparatorCereal containing 3g high molecular weight oat beta glucan
Receives: Dietary Supplement: 3g high MW
4g medium MWActive comparatorCereal containing 4g oat beta glucan with medium molecular weight
Receives: Dietary Supplement: 4g medium MW
3g medium MWActive comparatorCereal containing 3g oat beta glucan with medium molecular weight
Receives: Dietary Supplement: 3g medium MW
4g low MWActive comparatorCereal containing 4g oat beta glucan with low molecular weight
Receives: Dietary Supplement: 4g low MW

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4 weeks

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

    Measured: 4 weeks

Secondary outcomes (14)

  1. Total cholesterol

    Measured: 4 weeks

  2. Serum triglycerides

    Measured: 4 weeks

  3. Serum HDL cholesterol

    Measured: 4 weeks

  4. Fasting serum glucose

    Measured: 4 weeks

  5. Serum aspartate transaminase

    Measured: 4 weeks

  6. serum c-reactive protein

    Measured: 4 weeks

  7. Serum urea

    Measured: 4 weeks

  8. Serum creatinine

    Measured: 4 weeks

  9. Time course of changes in blood lipids

    Measured: 4 weeks

  10. Blood pressure

    Measured: 4 weeks

  11. Macronutrient composition of diet

    Measured: 4 weeks

  12. Symptoms questionnaire

    Measured: 4 weeks

  13. apolipoprotein B

    Measured: 4 weeks

  14. Serum markers of cholesterol absorption and synthesis

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionJul 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00981981
Sponsor's protocol ID
GIL8034
Acronym
Bluebird
Status last verified
Jun 2011
First submitted
18 Sep 2009
Last updated
21 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20660224

  • 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.

    PubMed 20527967

  • 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.

    PubMed 22118569

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Wheat bran, 3g high MW and 4g medium MW in people with Hypercholesterolemia, run by Glycemic Index Laboratories, Inc at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum LDL-cholesterol lowering effect of 3g high MW beta-glucan (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00981981, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2011.

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