Oat and Cholesterol

Not Applicable

Completed

• Conditions: Elevated LDL Cholesterol
• Interventions: Other: Active oat beverage; Other: Control rice beverage

• Registration Number: NCT03911427
• Lead Sponsor: PepsiCo Global R&D

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study Start: 2019-04-10
• Study First Posted: 2019-04-11
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Powder Mix 1	Active oat beverage	Oat powder product, mixed with water
Powder Mix 2	Control rice beverage	Brown rice milk powder product, mixed with water

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 insulin	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 serum total cholesterol	Baseline vs. Week 4	Reduction in mmol/L is a better outcome

Trial Locations

Locations (1)

Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor; 🇨🇦 Toronto, Ontario, Canada