Oat Phenolics Bioavailability

October 9, 2015 updated by: Jeremy Paul Edward Spencer, University of Reading

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline and 48 hours
Baseline and 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

PepsiCo Global R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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