Oat and Cholesterol

Elevated LDL Cholesterol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911427
• Other study ID #: PEP-1801
• Status: Completed
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2020
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 28, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Elevated LDL Cholesterol

Intervention

Other:
• Active oat beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
• Control rice beverage
Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
PepsiCo Global R&D	Glycemic Index Laboratories, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in fasting serum total cholesterol	Reduction in mmol/L is a better outcome	Baseline vs. Week 4
Secondary	Change in fasting serum HDL cholesterol	Increase in mmol/L is a better outcome	Baseline vs. Week 4
Secondary	Change in fasting non-HDL-cholesterol	Reduction in mmol/L is a better outcome	Baseline vs. Week 4
Secondary	Change in fasting triglycerides	Reduction in mmol/L is a better outcome	Baseline vs. Week 4
Secondary	Change in fasting glucose	Reduction in mmol/L is a better outcome	Baseline vs. Week 4
Secondary	Change in fasting insulin	Reduction in mmol/L is a better outcome	Baseline vs. Week 4
Secondary	Change in fasting glycated albumin	% reduction is a better outcome. Normal range is 11-17% of total albumin.	Baseline vs. Week 4
Secondary	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
Secondary	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