The effects of a high oat diet on risk factors of heart disease and their link with gut health

Not Applicable

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN11665494
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-03
• Study Completion: 2015-09-30
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Males and females
2. Aged 40-65 years
3. BMI 18.5-30.0
4. Systolic blood pressure > 90 and < 160, diastolic blood pressure > 60 and <99. Blood pressure will be measured at the screening appointment, and if greater than 140 / 90 the volunteer will be referred to their GP before participation. If they are subsequently put onto blood pressure medication then they will be excluded from the study

Exclusion Criteria

1. History of CVD
2. History of diabetes or previously diagnosed impaired glucose tolerance (fasted glucose >7.0mmol/l and 2 hour glucose levels following a glucose load of =7.8 and <11.1 mmol/l)
3. Untreated thyroid disorders
4. Presence of rheumatoid arthritis
5. Presence of asthma
6. Presence of inflammatory bowel disease
7. Presence of autoimmune disorders
8. Presence of cancer
9. Taking any medication or supplements that are prone to affecting any outcome measures including medication for blood pressure and hypercholesterolaemia
10. Use of n3 fatty acid supplements
11. Taken a course of antibiotics within the last three months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Blood pressure is measured after a 10 minute recumbent rest period. A minimum of 3 readings are taken and the first one is discarded. 24-hour blood pressure monitors are also used for the 24-hour following each timepoint. Readings are taken every 30 minutes between 7am and 10pm and then every hour from 10pm to 7am<br> 2. Faecal samples are collected at each timepoint and analysed for bacterial composition and short chain fatty acid concentrations<br><br> All primary outcomes are measured at the timepoints of weeks 0, 4, 10 and 16, with weeks 4 to 16 being the 12 week intervention period.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Fasted blood samples are analysed for blood lipid and glucose profiles and a range of inflammatory markers associated with cardiovascular disease, as well as short chain fatty concentrations<br> 2. Urine samples are collected at weeks 4 and 16 and analysed for avenanthramide concentration as a marker of dietary compliance<br><br> Secondary outcomes are measured at the timepoints weeks 0, 4, 10 and 16, with weeks 4 to 16 being the 12 week intervention period.<br>