Oat Phenolics Bioavailability

NCT ID: NCT02574039

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oat bran

66g oat bran made up in 350ml skimmed milk

Group Type EXPERIMENTAL

Oat bran

Intervention Type DIETARY_SUPPLEMENT

66g oat bran made up in 350ml skimmed milk

Control

Refined grain product and 350ml skimmed milk

Group Type PLACEBO_COMPARATOR

refined grain

Intervention Type DIETARY_SUPPLEMENT

refined grain product and 350ml skimmed milk

Interventions

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Oat bran

66g oat bran made up in 350ml skimmed milk

Intervention Type DIETARY_SUPPLEMENT

refined grain

refined grain product and 350ml skimmed milk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Food and Nutritional Sciences

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PROGRAIN1

Identifier Type: -

Identifier Source: org_study_id

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