Oat Phenolics Bioavailability

Absorption, Metabolism and Excretion of Oat Phenolic Acids in Healthy Men.

A diet rich in whole grain is inversely associated with cardiovascular disease risk and this benefit could be partly attributed to the phenolic acid content of whole grains. The exact absorption, metabolism and excretion of whole grain phenolic acids, however, is not fully understood. In a small human intervention trial, the investigators will investigate to what extent phenolic acids from whole grain oats are absorbed, excreted in urine and how they are metabolised.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Oat bran; Dietary supplement: refined grain

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Department of Food and Nutritional Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Males
• 25 to 65 years old

Exclusion Criteria:

• Allergies to oats
• Parallel participation in another research project
• Having flu vaccination or antibiotics within 3 months of trial start
• Taking food supplements within 3 months of trial start
• Past or existing medical history of vascular disease, diabetes, hepatic, renal, gastrointestinal, haematological, neurological, thyroidal disease or cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oat bran; 66g oat bran made up in 350ml skimmed milk	Dietary supplement: Oat bran; 66g oat bran made up in 350ml skimmed milk
Placebo Comparator: Control; Refined grain product and 350ml skimmed milk	Dietary supplement: refined grain; refined grain product and 350ml skimmed milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in phenolic acid metabolite excretion	Baseline and 48 hours

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: PepsiCo Global R&D

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: October 9, 2015
• First Posted (Estimate): October 12, 2015

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: October 9, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: volunteers; bioavailability; oat; phenolic acid
• Other Study ID Numbers: PROGRAIN1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No