NCT03946293

Brief Summary

This study evaluates the impact of a high phenolic acid intake from wholegrain wheat bread on human vascular function and plasma phenolic acid concentrations in healthy adults. All participants received a high fibre flatbread with enzymatically released free FA (14.22 mg), an equivalent standard high fibre bread (2.34 mg), or a white bread control (0.48 mg).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 8, 2019

Last Update Submit

May 9, 2019

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilatation (FMD)

    FMD of the brachial artery

    Change from baseline to 5 hours

Secondary Outcomes (3)

  • Plasma phenolic acids

    Change from baseline to 24 hours

  • Laser Doppler Imaging with iontophoresis

    Change from baseline to 5 hours

  • Digital Volume Pulse (DVP)

    Change from baseline to 5 hours

Study Arms (3)

White bread

ACTIVE COMPARATOR

White bread 3 x 30 g, single serving

Dietary Supplement: White Bread

Wholegrain

ACTIVE COMPARATOR

Standard wholegrain, 3 x 30 g, single serving

Dietary Supplement: Wholegrain bread

Wholegrain Enzyme

EXPERIMENTAL

Enzyme-treated wholegrain, 3 x 30 g, single serving

Dietary Supplement: Wholegrain Enzyme

Interventions

White BreadDIETARY_SUPPLEMENT

White bread made with commercial white flour with bran/fibre removed

White bread
Wholegrain breadDIETARY_SUPPLEMENT

Wholegrain bread made with commercial wholegrain flour.

Wholegrain
Wholegrain EnzymeDIETARY_SUPPLEMENT

Wholegrain bread made with enzyme-treated commercial wholegrain flour.

Wholegrain Enzyme

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \) fasting lipids in the upper half of the normal range (triacylglycerol 0.8-3.2 mmol/l and total cholesterol 6.0-8.0 mmol/l); 2) BMI 25-32 kg/m2; 3) non-smoker; 4) not diabetic (diagnosed or fasting glucose \< 7 mmol/l) or suffer from endocrine disorders; 5) hemoglobin and liver enzymes levels within the normal range \[Alanine Transaminase (ALT): 0-55 IU/L; Alkaline Phosphatase (ALP): 38-126 U/L; Aspartate Transaminase (AST): 0-45 IU/L; Gamma Glutamyl Transferase (GGT): 12-58 IU/L\]); 6) not having suffered a myocardial infarction/stroke in the past 12 months; 7) not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis; 8) not on drug treatment for hyperlipidemia, hypertension, inflammation or hyper-coagulation; 9) not taking any fish oil, fatty acid or vitamin and mineral supplements; 10) no history of alcohol misuse; 11) not planning, or on a weight reduction regime; 12) not having taken antibiotics in the 6 months prior to the study; and 13) being able to consume the study interventions.

You may not qualify if:

  • Gluten sensitive

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

Related Publications (1)

  • Turner AL, Michaelson LV, Shewry PR, Lovegrove A, Spencer JPE. Increased bioavailability of phenolic acids and enhanced vascular function following intake of feruloyl esterase-processed high fibre bread: A randomized, controlled, single blind, crossover human intervention trial. Clin Nutr. 2021 Mar;40(3):788-795. doi: 10.1016/j.clnu.2020.07.026. Epub 2020 Aug 8.

    PMID: 33077275DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutritional Medicine

Study Record Dates

First Submitted

May 8, 2019

First Posted

May 10, 2019

Study Start

January 5, 2015

Primary Completion

June 30, 2015

Study Completion

November 15, 2015

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)