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Phenolic-rich Oats and Artery Improvement (PROGRAIN2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02731755
Recruitment Status : Completed
First Posted : April 8, 2016
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Collaborators:
Biotechnology and Biological Sciences Research Council
Rothamsted Research
PepsiCo Global R&D
University of Roehampton
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Healthy
Interventions Other: Oat
Other: Control
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oat Then Control Control Then Oat
Hide Arm/Group Description The first intervention is oat, the second intervention is control The first intervention is control, the second intervention is oat
Period Title: First Intervention
Started 8 10
Completed 8 8
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Period Title: Second Intervention
Started 8 8
Completed 8 8
Not Completed 0 0
Arm/Group Title All Participant
Hide Arm/Group Description Crossover study - All participant
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
47  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
16
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 16 participants
16
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants
133.9  (2.2)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 16 participants
81.1  (1.0)
1.Primary Outcome
Title Flow Mediated Dilatation
Hide Description Technique to assess the flexibility of the endothelium in larger peripheral blood vessels
Time Frame 1 hour, 6 hours and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Excluded data from 2 volunteers as their results were out of the normal range
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 14 14
Mean (Standard Error)
Unit of Measure: metre
1h 4.4  (0.7) 3.9  (0.9)
6h 3.4  (0.6) 4.4  (0.8)
24h 4.4  (0.4) 3.6  (0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oat Intervention, Control
Comments Between time points and treatments, calculated p value
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Laser Doppler Iontophoresis
Hide Description 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
Time Frame Baseline(BL), 2hours and 24hours
Hide Outcome Measure Data
Hide Analysis Population Description
Excluded data from 2 volunteers as their results were out of the normal range
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 14 14
Mean (Standard Error)
Unit of Measure: PU per hour
Ach-i AUC, BL 538.2  (90.4) 465  (70.6)
Ach-i AUC, 2h 681.8  (182) 463.7  (55.4)
Ach-i AUC, 24h 381.3  (61.4) 315  (45.5)
SNP-iAUC BL 661.1  (52.4) 757.1  (43.2)
SNP-iAUC 2h 709.4  (68.4) 502.9  (25.6)
SNP-iAUC,24h 622.4  (50.6) 513.7  (35.8)
Ach-AUC, BL 1593.9  (198.9) 1534.1  (144.2)
Ach-AUC, 2h 1678.3  (140.6) 1358.3  (116.9)
Ach-AUC, 24h 1560.9  (161.3) 1701.6  (190.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oat Intervention, Control
Comments Ach-iAUC
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Oat Intervention, Control
Comments SNP-IAUC
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Oat Intervention, Control
Comments Ach - AUC
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Phenolic Acids Metabolites - Ferulic Acid
Hide Description Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h
Time Frame Baseline, 1hour, 2 hours and 24hours
Hide Outcome Measure Data
Hide Analysis Population Description
Excluded data from 2 volunteers as their results were out of the normal range
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: nanomolars
BL 10.6  (7.8) 0.4  (2.4)
1h 33.9  (17.5) 9  (6.4)
2h 153.5  (145.2) 10.3  (9.3)
24h 373  (4) 222  (24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oat Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Plasma Nitric Oxide Analysis
Hide Description Concentration of nitric oxide in nmol
Time Frame Acute postprandial timecourse from Baseline, 1hour to 24hours.
Hide Outcome Measure Data
Hide Analysis Population Description
No data collected
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title NADPH Oxidase Activity in Neutrophil Blood Cells
Hide Description NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer
Time Frame Baseline, 2 hours and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Excluded data from 2 volunteers as their results were out of the normal range
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 14 14
Mean (Standard Error)
Unit of Measure: fluorescence intensity
BL 55.7  (7) 58.6  (8)
2h 43.6  (5) 47.9  (8)
24h 63.6  (6) 61.6  (9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oat Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Plasma Glucose
Hide Description Glucose concentration in mmol/L
Time Frame Acute postprandial timecourse from Baseline, 1hour to 24hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Plasma Insulin
Hide Description Insulin concentration in pmol/L
Time Frame Acute postprandial timecourse from Baseline, 1hour to 24hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Renin Activity
Hide Description Renin activity in ng/(mL*hour)
Time Frame Acute postprandial timecourse from Baseline, 1hour to 24hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description:
The first intervention is oat, the second intervention is control
The first intervention is control, the second intervention is oat
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oat Intervention Control
Hide Arm/Group Description Participants received oat intervention Participants received control intervention
All-Cause Mortality
Oat Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
Oat Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oat Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      0/18 (0.00%)    
Nervous system disorders     
Faint * 1  1/18 (5.56%)  1 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof Jeremy Spencer
Organization: University of Reading
Phone: +44(0) 1183788724
EMail: j.p.e.spencer@reading.ac.uk
Layout table for additonal information
Responsible Party: Jeremy Paul Edward Spencer, University of Reading
ClinicalTrials.gov Identifier: NCT02731755    
Other Study ID Numbers: PROGRAIN2
First Submitted: February 9, 2016
First Posted: April 8, 2016
Results First Submitted: September 22, 2019
Results First Posted: November 1, 2019
Last Update Posted: November 1, 2019