Hypercholesterolemia
Conditions
Keywords
humans, randomized clinical trial, dietary fiber, nutrition, beta-glucan, oats, LDL cholesterol, coronary heart disease
Brief 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. To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced when the molecular weight of the fiber was reduced.
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.
Interventions
DIETARY_SUPPLEMENTWheat bran
21g per day of ready to eat breakfast cereal containing wheat bran with 8g of total dietary fiber and 0.5g beta-glucan.
DIETARY_SUPPLEMENT3g high MW
20.2 grams per day of ready to eat cereal containing 6g total dietary fiber and 3g oat beta glucan with high molecular weight
DIETARY_SUPPLEMENT4g medium MW
28.5g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with medium molecular weight
DIETARY_SUPPLEMENT3g medium MW
21.1g of ready to eat cereal containing 6g total fiber and 3g oat beta glucan with a medium molecular weight
DIETARY_SUPPLEMENT4g low MW
28.7g ready to eat cereal containing 8g total dietary fiber and 4g oat beta glucan with low molecular weight
Sponsors
CreaNutrition, AG
University of Guelph
University of Sydney
Laval University
Reading Scientific Services Ltd.
University of Toronto
Agriculture and Agri-Food Canada
Glycemic Index Laboratories, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum HDL cholesterol | 4 weeks |
| Fasting serum glucose | 4 weeks |
| Serum aspartate transaminase | 4 weeks |
| serum c-reactive protein | 4 weeks |
| Serum urea | 4 weeks |
| Serum creatinine | 4 weeks |
| Total cholesterol | 4 weeks |
| Blood pressure | 4 weeks |
| Macronutrient composition of diet | 4 weeks |
| Symptoms questionnaire | 4 weeks |
| apolipoprotein B | 4 weeks |
| Serum markers of cholesterol absorption and synthesis | 4 weeks |
| Time course of changes in blood lipids | 4 weeks |
| Serum triglycerides | 4 weeks |
Countries
Australia, Canada, United Kingdom
Outcome results
None listed