Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure

July 27, 2016 updated by: Jeremy Paul Edward Spencer, University of Reading
In this proposed human trial, the investigators aim to establish whether 4 weeks of daily consumption of beta-glucan matched meals providing either a high dose or a moderate dose of oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in markers of CVD risk and gut health relative to an energy matched control intervention in healthy adults with above average blood pressure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • To investigate the chronic effects of daily intake of oat products on flow mediated dilatation of the brachial artery (FMD; primary endpoint), microvascular endothelial function (measured by laser Doppler iontophoresis), pulse wave analysis, gut microbiota diversity, 24h blood pressure, activity of the renin angiotensin system, markers related to cellular production of nitric oxide and reactive oxygen species, inflammatory cytokines, and further potentially emerging biochemical markers of CVD risk.
  • To establish if phenolic acids and avenanthramides from oat products exert cardiovascular and microbial effects in a dose dependent manner.
  • To measure urinary and fecal excretion of avenanthramide and phenolic acid metabolites.

To explore correlations between bacterial population changes and CVD risk markers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Reading, United Kingdom, RG66AP
        • Recruiting
        • Hugh Sinclair Unit of Human Nutrition
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Manuel Y Schar, PDRA
        • Principal Investigator:
          • Jeremy P Spencer, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg)

Exclusion Criteria:

  • Abnormal biochemical, haematological results as assessed at health screening
  • Hypertension (i.e. SBP/DBP ≥160/100 mm Hg)
  • BMI >35
  • Current smoker or ex-smoker ceasing <3 months ago
  • Past or existing medical history of vascular disease, diabetes, hepatic, renal, haematological, neurological, thyroidal disease or cancer
  • Prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. Viagra), anti-inflammatory, antibiotic or antidepressant medication
  • Allergies to whole grains
  • Parallel participation in another research project
  • Having flu vaccination or antibiotics within 3 months of trial start
  • Chronic constipation, diarrhea or other chronic gastrointestinal complaint
  • On a weight reduction regime or taking food, probiotics or prebiotics supplements or laxative within 3 months of trial start
  • Performing high level of physical activity (i.e. ≥150min aerobic exercise/week)
  • Consumption of ≥21 units of alcohol/week
  • Females who are breast-feeding, may be pregnant, lactating or, if of reproductive age and not using a reliable form of contraception (including abstinence)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High avenanthramide, phenolic acid
66.8g Pepsico Oatmeal + 60g Oat cake
Other: High avenanthramide, phenolic acid
High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
Active Comparator: Low avenanthramide, medium phenolic acid
17g Oatwell + 63.6g Cream of Rice + 60g Melba Toast
Other: Low avenanthramide, medium phenolic acid
Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
Placebo Comparator: Control
69.8g Cream of Rice + 8.1g Cellulose + 4.8g Pectin + 60g Melba Toast
Other: Control
Control are matched with energy and insoluable fibre.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flow mediated dilatation
Time Frame: 20 weeks
Technique to assess the flexibility of teh endothelium in larger peripheral blood vessels, magnitude of increase in percentage from baseline to after 4 weeks treatment.
20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Laser Doppler Iontophoresis
Time Frame: 20 weeks
Magnitude of increase from Baseline to 4weeks treatment
20 weeks
Gut microbiota changes
Time Frame: 22 weeks
Gut microbiota diversity and relative abduance change from Baseline to 4weeks treatment
22 weeks
Plasma nitric oxide analysis
Time Frame: 22 weeks
Concentration of nitric oxide in nmol from Baseline to 4weeks treatment
22 weeks
NADPH oxidase activity in neutrophil blood cells
Time Frame: 22 weeks
NADPH oxidase activity will be calculated as the difference between values obtained in PMA from Baseline to 4weeks treatment
22 weeks
Inflammatory markers
Time Frame: 22 weeks
Inflammatory marker levels change from Baseline to 4weeks treatment
22 weeks
Renin activity
Time Frame: 22 weeks
Renin activity in ng/(mL*hour)
22 weeks
Plasma microparticles
Time Frame: 22 weeks
Microparticles in counts/uL
22 weeks
Urine and plasma metabolomic footprint using NMR
Time Frame: 22 weeks
22 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma glucose
Time Frame: 22 weeks
Glucose concentration in mmol/L
22 weeks
Plasma insulin
Time Frame: 22 weeks
Insulin concentration in uU/mL
22 weeks
Plasma lipids
Time Frame: 22 weeks
Plasma lipid concentration in mmol/L
22 weeks
Faecal water metabolites
Time Frame: 22 weeks
Metabolites in mikrogram/L
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Reading

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biotechnology and Biological Sciences Research Council
PepsiCo, Inc.
Rothamsted Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeremy P Spencer, Professor, University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Prograin3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publish

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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