Clinical trial NCT03911427: Oat and Cholesterol
Official title: Impact of Oat Product on LDL Cholesterol in Healthy Men and Women With Elevated LDL-cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated LDL Cholesterol
Keywords: Beverage
Beta glucan
Fiber
Oat
Hypercholesterolemia
LDL
Cholesterol
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
Collaborators: name: Glycemic Index Laboratories, Inc
First posted: 2019-04-11
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in fasting serum LDL-cholesterol
timeFrame: Baseline vs. Week 4
Secondary outcomes:
measure: Change in fasting serum total cholesterol
timeFrame: Baseline vs. Week 4
measure: Change in fasting serum HDL cholesterol
timeFrame: Baseline vs. Week 4
measure: Change in fasting non-HDL-cholesterol
timeFrame: Baseline vs. Week 4
measure: Change in fasting triglycerides
timeFrame: Baseline vs. Week 4
measure: Change in fasting glucose
timeFrame: Baseline vs. Week 4
measure: Change in fasting insulin
timeFrame: Baseline vs. Week 4
measure: Change in fasting glycated albumin
timeFrame: Baseline vs. Week 4
measure: Change in fasting HOMA-IR
timeFrame: Baseline vs. Week 4
measure: Change in Framingham risk score
timeFrame: Baseline vs. Week 4
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ms Wolever T, Rahn M, Dioum E, Spruill SE, Ezatagha A, Campbell JE, Jenkins AL, Chu Y. An Oat beta-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.