Trial Outcomes & Findings for Phenolic-rich Oats and Artery Improvement (NCT NCT02731755)

Results Overview

Technique to assess the flexibility of the endothelium in larger peripheral blood vessels

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

1 hour, 6 hours and 24 hours

Results posted on

2019-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Oat Then Control The first intervention is oat, the second intervention is control	Control Then Oat The first intervention is control, the second intervention is oat
First Intervention STARTED	8	10
First Intervention COMPLETED	8	8
First Intervention NOT COMPLETED	0	2
Second Intervention STARTED	8	8
Second Intervention COMPLETED	8	8
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Oat Then Control The first intervention is oat, the second intervention is control	Control Then Oat The first intervention is control, the second intervention is oat
First Intervention Withdrawal by Subject	0	2

Baseline Characteristics

Phenolic-rich Oats and Artery Improvement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participant n=16 Participants Crossover study - All participant
Age, Continuous	47 years STANDARD_DEVIATION 4 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United Kingdom	16 participants n=99 Participants
Systolic blood pressure	133.9 mmHg STANDARD_DEVIATION 2.2 • n=99 Participants
Diastolic blood pressure	81.1 mmHg STANDARD_DEVIATION 1.0 • n=99 Participants

PRIMARY outcome

Timeframe: 1 hour, 6 hours and 24 hours

Population: Excluded data from 2 volunteers as their results were out of the normal range

Technique to assess the flexibility of the endothelium in larger peripheral blood vessels

Outcome measures

Outcome measures
Measure	Oat Intervention n=14 Participants The first intervention is oat, the second intervention is control	Control n=14 Participants The first intervention is control, the second intervention is oat
Flow Mediated Dilatation 1h	4.4 metre Standard Error 0.7	3.9 metre Standard Error 0.9
Flow Mediated Dilatation 6h	3.4 metre Standard Error 0.6	4.4 metre Standard Error 0.8
Flow Mediated Dilatation 24h	4.4 metre Standard Error 0.4	3.6 metre Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline(BL), 2hours and 24hours

Population: Excluded data from 2 volunteers as their results were out of the normal range

Acute postprandial timecourse from Baseline to 2 hours, 24hours, AUC - area under the blood flow and time curve Ach-iAUC-endothelium dependent incremental area under the curve SNP-iAUC-endothelium independent incremental area under the curve Ach-AUC- endothelium dependent area under the curve

Outcome measures

Outcome measures
Measure	Oat Intervention n=14 Participants The first intervention is oat, the second intervention is control	Control n=14 Participants The first intervention is control, the second intervention is oat
Laser Doppler Iontophoresis Ach-i AUC, BL	538.2 PU per hour Standard Error 90.4	465 PU per hour Standard Error 70.6
Laser Doppler Iontophoresis Ach-i AUC, 2h	681.8 PU per hour Standard Error 182	463.7 PU per hour Standard Error 55.4
Laser Doppler Iontophoresis Ach-i AUC, 24h	381.3 PU per hour Standard Error 61.4	315 PU per hour Standard Error 45.5
Laser Doppler Iontophoresis SNP-iAUC BL	661.1 PU per hour Standard Error 52.4	757.1 PU per hour Standard Error 43.2
Laser Doppler Iontophoresis SNP-iAUC 2h	709.4 PU per hour Standard Error 68.4	502.9 PU per hour Standard Error 25.6
Laser Doppler Iontophoresis SNP-iAUC,24h	622.4 PU per hour Standard Error 50.6	513.7 PU per hour Standard Error 35.8
Laser Doppler Iontophoresis Ach-AUC, BL	1593.9 PU per hour Standard Error 198.9	1534.1 PU per hour Standard Error 144.2
Laser Doppler Iontophoresis Ach-AUC, 2h	1678.3 PU per hour Standard Error 140.6	1358.3 PU per hour Standard Error 116.9
Laser Doppler Iontophoresis Ach-AUC, 24h	1560.9 PU per hour Standard Error 161.3	1701.6 PU per hour Standard Error 190.9

SECONDARY outcome

Timeframe: Baseline, 1hour, 2 hours and 24hours

Population: Excluded data from 2 volunteers as their results were out of the normal range

Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h

Outcome measures

Outcome measures
Measure	Oat Intervention n=14 Participants The first intervention is oat, the second intervention is control	Control n=14 Participants The first intervention is control, the second intervention is oat
Phenolic Acids Metabolites - Ferulic Acid BL	10.6 nanomolars Standard Deviation 7.8	0.4 nanomolars Standard Deviation 2.4
Phenolic Acids Metabolites - Ferulic Acid 1h	33.9 nanomolars Standard Deviation 17.5	9 nanomolars Standard Deviation 6.4
Phenolic Acids Metabolites - Ferulic Acid 2h	153.5 nanomolars Standard Deviation 145.2	10.3 nanomolars Standard Deviation 9.3
Phenolic Acids Metabolites - Ferulic Acid 24h	373 nanomolars Standard Deviation 4	222 nanomolars Standard Deviation 24

SECONDARY outcome

Timeframe: Acute postprandial timecourse from Baseline, 1hour to 24hours.

Population: No data collected

Concentration of nitric oxide in nmol

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 2 hours and 24 hours

Population: Excluded data from 2 volunteers as their results were out of the normal range

NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer

Outcome measures

Outcome measures
Measure	Oat Intervention n=14 Participants The first intervention is oat, the second intervention is control	Control n=14 Participants The first intervention is control, the second intervention is oat
NADPH Oxidase Activity in Neutrophil Blood Cells BL	55.7 fluorescence intensity Standard Error 7	58.6 fluorescence intensity Standard Error 8
NADPH Oxidase Activity in Neutrophil Blood Cells 2h	43.6 fluorescence intensity Standard Error 5	47.9 fluorescence intensity Standard Error 8
NADPH Oxidase Activity in Neutrophil Blood Cells 24h	63.6 fluorescence intensity Standard Error 6	61.6 fluorescence intensity Standard Error 9

SECONDARY outcome

Timeframe: Acute postprandial timecourse from Baseline, 1hour to 24hours.

Population: Data not collected

Glucose concentration in mmol/L

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Acute postprandial timecourse from Baseline, 1hour to 24hours.

Population: Data not collected

Insulin concentration in pmol/L

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Acute postprandial timecourse from Baseline, 1hour to 24hours.

Population: Data not collected

Renin activity in ng/(mL\*hour)

Outcome measures

Outcome data not reported

Adverse Events

Oat Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oat Intervention n=18 participants at risk Participants received oat intervention	Control n=18 participants at risk Participants received control intervention
Nervous system disorders Faint	5.6% 1/18 • Number of events 1 • 2 months	0.00% 0/18 • 2 months

Additional Information

Prof Jeremy Spencer

University of Reading

Phone: +44(0) 1183788724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place