Oat and Cholesterol

NCT03911427 | Completed

• 1 other identifier: PEP-1801
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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

Conditions

Elevated LDL Cholesterol

Keywords

Beverage; Beta glucan; Fiber; Oat; Hypercholesterolemia; LDL; Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in fasting serum total cholesterol

  Baseline vs. Week 4

• Change in fasting serum HDL cholesterol

  Baseline vs. Week 4

• Change in fasting non-HDL-cholesterol

  Baseline vs. Week 4

• Change in fasting triglycerides

  Baseline vs. Week 4

• Change in fasting glucose

  Baseline vs. Week 4

Study Arms (2)

Powder Mix 1

EXPERIMENTAL

Oat powder product, mixed with water

Other: Active oat beverage

Powder Mix 2

PLACEBO COMPARATOR

Brown rice milk powder product, mixed with water

Other: Control rice beverage

Interventions

Active oat beverage OTHER

Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month

Powder Mix 1

Control rice beverage OTHER

Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month

Powder Mix 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fasting LDL cholesterol 116-193 mg/dl (3-5 mmol/L)
• Males and non-pregnant, non-lactating females 18-65 years
• Agree to consume the investigational product three times daily for the duration of the study
• BMI 18.5 to 39.9 kg/m2
• Blood pressure \<160/100 mmHg
• Fasting triglycerides \<4.0 mmol/L
• Fasting serum glucose \<126mg/dL (\<7 mmol/L)
• Serum urea and creatinine \< 1.8 times upper limit of normal (ULN)
• Serum aspartate aminotransaminase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) \< 2 times ULN
• Hemoglobin \> 0.9 times lower limit of normal and \< 1.1 times ULN
• Have a stable body weight (\<7 kg change) over the past 3-months
• Absence of health conditions that would prevent fulfillment of study requirements

You may not qualify if:

• Pregnancy, breastfeeding or planning to be pregnant
• Allergy or sensitivity to study product ingredients
• Dislike description of study product
• Diet containing ≥15% of energy from saturated fat
• Consuming \>20g fiber/per 1000 Kcal or \>40g fiber/day (including soluble fiber supplements)
• Consumption of more than 2 drinks of alcohol per day, or more than 14 drinks per week
• Extreme dietary habits
• Smoking \>5 cigarettes or equivalent per day
• Use of cholesterol lowering medication or prescription drug or for treating diabetes mellitus within 4 weeks of randomization
• Active major gastrointestinal disorder
• Major trauma or hospitalization for a medical condition or major surgical event within 6 months of randomization
• History of cancer within two years or randomization, except for non-melanoma skin cancer
• 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

Sponsors & Collaborators

• PepsiCo Global R&D: lead
• Glycemic Index Laboratories, Inc: collaborator

Study Sites (1)

Glycemic Index Laboratories, Inc. 20 Victoria Street, 3rd Floor

Toronto, Ontario, M5C 2N8, Canada

Location

Related Publications (1)

• 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.

  PMID: 34236436 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Gyrate Atrophy; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Eye Diseases, Hereditary; Eye Diseases; Choroid Diseases; Uveal Diseases

Study Officials

• Thomas MS Wolever, MD, PhD

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: April 10, 2019
• Primary Completion: February 20, 2020
• Study Completion: February 28, 2020
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)