NCT02574039

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

3 months

First QC Date

June 26, 2015

Last Update Submit

October 9, 2015

Conditions

Healthy

Keywords

volunteersoatphenolic acidbioavailability

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in phenolic acid metabolite excretion

    Baseline and 48 hours

Study Arms (2)

Oat bran

EXPERIMENTAL

66g oat bran made up in 350ml skimmed milk

Dietary Supplement: Oat bran

Control

PLACEBO COMPARATOR

Refined grain product and 350ml skimmed milk

Dietary Supplement: refined grain

Interventions

Oat branDIETARY_SUPPLEMENT

66g oat bran made up in 350ml skimmed milk

Oat bran
refined grainDIETARY_SUPPLEMENT

refined grain product and 350ml skimmed milk

Control

Eligibility Criteria

Age25 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males
  • to 65 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Gyrate Atrophy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesChoroid DiseasesUveal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2015

First Posted

October 12, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

GB(1)