The primary objective is to assess the effect of an oat ingredient provided over 4 weeks on serum LDL cholesterol in men and women with elevated LDL-cholesterol compared to a placebo. Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol, triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
207
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor
Toronto, Ontario, Canada
Change in fasting serum LDL-cholesterol
Reduction in mmol/L is a better outcome and \>=5% reduction would be significant
Time frame: Baseline vs. Week 4
Change in fasting serum total cholesterol
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Change in fasting serum HDL cholesterol
Increase in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Change in fasting non-HDL-cholesterol
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Change in fasting triglycerides
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Change in fasting glucose
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Change in fasting insulin
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Change in fasting glycated albumin
% reduction is a better outcome. Normal range is 11-17% of total albumin.
Time frame: Baseline vs. Week 4
Change in fasting HOMA-IR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Reduction is a better outcome. Calculated from serum glucose mmol/L and insulin uU/ml. G×I/22.5, where G is fasting serum glucose in mmol/L and I is fasting serum insulin in uU/mL. Less than 1.0 means insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Time frame: Baseline vs. Week 4
Change in Framingham risk score
Reduction is a better outcome. 10 year risk for cardiovascular disease = total points expressed as % for men and women. Calculated from sex, age, total and HDL cholesterol (mg/dL), systolic blood pressure (mmHg), smoking (yes/no) and diabetes (yes/no) using the equations given on the Framingham Heart Study website.
Time frame: Baseline vs. Week 4