Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure
NCT ID: NCT02847312
Last Updated: 2016-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2016-07-31
2017-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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High avenanthramide, phenolic acid
66.8g Pepsico Oatmeal + 60g Oat cake
High avenanthramide, phenolic acid
High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
Low avenanthramide, medium phenolic acid
17g Oatwell + 63.6g Cream of Rice + 60g Melba Toast
Low avenanthramide, medium phenolic acid
Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
Control
69.8g Cream of Rice + 8.1g Cellulose + 4.8g Pectin + 60g Melba Toast
Control
Control are matched with energy and insoluable fibre.
Interventions
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High avenanthramide, phenolic acid
High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
Low avenanthramide, medium phenolic acid
Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
Control
Control are matched with energy and insoluable fibre.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
25 Years
75 Years
ALL
Yes
Sponsors
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PepsiCo, Inc.
INDUSTRY
Rothamsted Research
UNKNOWN
Biotechnology and Biological Sciences Research Council
OTHER
University of Reading
OTHER
Responsible Party
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Jeremy Paul Edward Spencer
Professor
Principal Investigators
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Jeremy P Spencer, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Reading
Locations
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Hugh Sinclair Unit of Human Nutrition
Reading, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Prograin3
Identifier Type: -
Identifier Source: org_study_id
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