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Completed

NCT Number: NCT00981981

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

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SUGiRS Human Nutrition Unit, School of Molecular & Microbial Biosciences, Unviersity of Sydney, Sydney, New South Wales, Australia

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About this study

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:

  • An extruded oat cereal containing 3g high-molecular weight oat β-glucan daily will reduce LDL cholesterol compared to a control wheat bran cereal.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Wheat Bran

Dietary 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 MW

Dietary 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 MW

Dietary Supplement

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

3g medium MW

Dietary Supplement

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

4g low MW

Dietary Supplement

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

Primary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

Secondary outcomes

  1. Total cholesterol

    Time frame: 4 weeks

  2. Serum triglycerides

    Time frame: 4 weeks

  3. Serum HDL cholesterol

    Time frame: 4 weeks

  4. Fasting serum glucose

    Time frame: 4 weeks

  5. Serum aspartate transaminase

    Time frame: 4 weeks

  6. serum c-reactive protein

    Time frame: 4 weeks

  7. Serum urea

    Time frame: 4 weeks

  8. Serum creatinine

    Time frame: 4 weeks

  9. Time course of changes in blood lipids

    Time frame: 4 weeks

  10. Blood pressure

    Time frame: 4 weeks

  11. Macronutrient composition of diet

    Time frame: 4 weeks

  12. Symptoms questionnaire

    Time frame: 4 weeks

  13. apolipoprotein B

    Time frame: 4 weeks

  14. Serum markers of cholesterol absorption and synthesis

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Glycemic Index Laboratories, Inc

Industry

Collaborators

  • Agriculture and Agri-Food Canada
  • CreaNutrition, AG
  • Laval University
  • Reading Scientific Services Ltd.
  • University of Guelph
  • University of Sydney
  • University of Toronto

Registry information

Official study title

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

Acronym: Bluebird

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2009
Registry last updated
Jun 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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