Oat and Cholesterol

PepsiCo

Status: Completed

Conditions: Elevated LDL Cholesterol

Treatments: Other: Active oat beverage; Other: Control rice beverage

Study type: Interventional

Funder types: Industry

Identifiers

NCT03911427

PEP-1801

Details and patient eligibility

About

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

Enrollment: 207 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

Powder Mix 1

Experimental group

Description:

Oat powder product, mixed with water

Treatment:

Other: Active oat beverage

Powder Mix 2

Placebo Comparator group

Description:

Brown rice milk powder product, mixed with water

Treatment:

Other: Control rice beverage