Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Glycemic Index Laboratories, Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powder Mix 1 | Experimental | Oat powder product, mixed with water |
|
| Powder Mix 2 | Placebo Comparator | Brown rice milk powder product, mixed with water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active oat beverage | Other | Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting serum LDL-cholesterol | Reduction in mmol/L is a better outcome and >=5% reduction would be significant | Baseline vs. Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting serum total cholesterol | Reduction in mmol/L is a better outcome | Baseline vs. Week 4 |
| Change in fasting serum HDL cholesterol | Increase in mmol/L is a better outcome |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas MS Wolever, MD, PhD | Glycemic Index Laboratories, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor | Toronto | Ontario | M5C 2N8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34236436 | Derived | Ms Wolever T, Rahn M, Dioum E, Spruill SE, Ezatagha A, Campbell JE, Jenkins AL, Chu Y. An Oat beta-Glucan Beverage Reduces LDL Cholesterol and Cardiovascular Disease Risk in Men and Women with Borderline High Cholesterol: A Double-Blind, Randomized, Controlled Clinical Trial. J Nutr. 2021 Sep 4;151(9):2655-2666. doi: 10.1093/jn/nxab154. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D015799 | Gyrate Atrophy |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control rice beverage | Other | Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month |
|
| Baseline vs. Week 4 |
| Change in fasting non-HDL-cholesterol | Reduction in mmol/L is a better outcome | Baseline vs. Week 4 |
| Change in fasting triglycerides | Reduction in mmol/L is a better outcome | Baseline vs. Week 4 |
| Change in fasting glucose | Reduction in mmol/L is a better outcome | Baseline vs. Week 4 |
| Change in fasting insulin | Reduction in mmol/L is a better outcome | Baseline vs. Week 4 |
| Change in fasting glycated albumin | % reduction is a better outcome. Normal range is 11-17% of total albumin. | Baseline vs. Week 4 |
| Change in fasting HOMA-IR | 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. | 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. | Baseline vs. Week 4 |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |