Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor
Toronto, Ontario, M5C 2N8, Canada
NCT Number: NCT03911427
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
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5C 2N8, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline vs. Week 4
Reduction in mmol/L is a better outcome and >=5% reduction would be significant
Time frame: Baseline vs. Week 4
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Increase in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
Reduction in mmol/L is a better outcome
Time frame: Baseline vs. Week 4
% reduction is a better outcome. Normal range is 11-17% of total albumin.
Time frame: Baseline vs. Week 4
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
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.
PepsiCo Global R&D
Industry
Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol
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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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