Oat and Cholesterol

Study Overview
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Brief Summary
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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

Official Title
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Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol

Conditions
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Elevated LDL Cholesterol

Intervention / Treatment
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* Other: Active oat beverage
* Other: Control rice beverage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L) Males and non-pregnant, non-lactating females 18-65 years Agree to consume the investigational product three times daily for the duration of the study BMI 18.5 to 39.9 kg/m2 Blood pressure <160/100 mmHg Fasting triglycerides <4.0 mmol/L Fasting serum glucose <126mg/dL (<7 mmol/L) Serum urea and creatinine < 1.8 times upper limit of normal (ULN) Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) < 2 times ULN Hemoglobin > 0.9 times lower limit of normal and < 1.1 times ULN Have a stable body weight (<7 kg change) over the past 3-months Absence of health conditions that would prevent fulfillment of study requirements Exclusion Criteria: Pregnancy, breastfeeding or planning to be pregnant Allergy or sensitivity to study product ingredients Dislike description of study product Diet containing ≥15% of energy from saturated fat Consuming >20g fiber/per 1000 Kcal or >40g fiber/day (including soluble fiber supplements) Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week Extreme dietary habits Smoking >5 cigarettes or equivalent per day Use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization Active major gastrointestinal disorder Major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization History of cancer within two years or randomization, except for non-melanoma skin cancer Any condition or substance use which might, in the opinion of the PI, make participation dangerous for the participant, lead to poor attendance or compliance or affect the results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powder Mix 1<br>Oat powder product, mixed with water | Other: Active oat beverage<br>* Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month<br>|
| Placebo Comparator: Powder Mix 2<br>Brown rice milk powder product, mixed with water | Other: Control rice beverage<br>* Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beverage, Beta glucan, Fiber, Oat, Hypercholesterolemia, LDL, Cholesterol