Elevated LDL Cholesterol
Conditions
Keywords
Beverage, Beta glucan, Fiber, Oat, Hypercholesterolemia, LDL, Cholesterol
Brief summary
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
Interventions
OTHERActive oat beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
OTHERControl rice beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Sponsors
Glycemic Index Laboratories, Inc
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L) 2. Males and non-pregnant, non-lactating females 18-65 years 3. Agree to consume the investigational product three times daily for the duration of the study 4. BMI 18.5 to 39.9 kg/m2 5. Blood pressure \<160/100 mmHg 6. Fasting triglycerides \<4.0 mmol/L 7. Fasting serum glucose \<126mg/dL (\<7 mmol/L) 8. Serum urea and creatinine \< 1.8 times upper limit of normal (ULN) 9. Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) \< 2 times ULN 10. Hemoglobin \> 0.9 times lower limit of normal and \< 1.1 times ULN 11. Have a stable body weight (\<7 kg change) over the past 3-months 12. Absence of health conditions that would prevent fulfillment of study requirements
Exclusion criteria
1. Pregnancy, breastfeeding or planning to be pregnant 2. Allergy or sensitivity to study product ingredients 3. Dislike description of study product 4. Diet containing ≥15% of energy from saturated fat 5. Consuming \>20g fiber/per 1000 Kcal or \>40g fiber/day (including soluble fiber supplements) 6. Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week 7. Extreme dietary habits 8. Smoking \>5 cigarettes or equivalent per day 9. Use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization 10. Active major gastrointestinal disorder 11. Major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization 12. History of cancer within two years or randomization, except for non-melanoma skin cancer 13. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting serum LDL-cholesterol | Baseline vs. Week 4 | Reduction in mmol/L is a better outcome and \>=5% reduction would be significant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting serum HDL cholesterol | Baseline vs. Week 4 | Increase in mmol/L is a better outcome |
| Change in fasting non-HDL-cholesterol | Baseline vs. Week 4 | Reduction in mmol/L is a better outcome |
| Change in fasting triglycerides | Baseline vs. Week 4 | Reduction in mmol/L is a better outcome |
| Change in fasting glucose | Baseline vs. Week 4 | Reduction in mmol/L is a better outcome |
| Change in fasting serum total cholesterol | Baseline vs. Week 4 | Reduction in mmol/L is a better outcome |
| Change in fasting glycated albumin | Baseline vs. Week 4 | % reduction is a better outcome. Normal range is 11-17% of total albumin. |
| Change in fasting HOMA-IR | 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. |
| Change in Framingham risk score | 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. |
| Change in fasting insulin | Baseline vs. Week 4 | Reduction in mmol/L is a better outcome |
Countries
Canada
Outcome results
None listed