Oat and Cholesterol

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

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

Study Overview

• Status: Completed
• Conditions: Elevated LDL Cholesterol
• Intervention / Treatment: Other: Active oat beverage; Other: Control rice beverage

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Collaborators: Glycemic Index Laboratories, Inc

Publications and helpful links

General Publications

• Ms Wolever T, Rahn M, Dioum E, Spruill SE, Ezatagha A, Campbell JE, Jenkins AL, Chu Y. An Oat β-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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cholesterol; Fiber; Hypercholesterolemia; LDL; Beverage; Beta glucan; Oat
• Other Study ID Numbers: PEP-1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No