Effect of a Mediterranean diet with fresh lean Australian pork on blood pressure, cardiovascular risk factors and cognition, mood and wellbeing in high risk individuals.

Not Applicable

Recruiting

• Conditions: Cardiovascular Health; Cardiometabolic Health; Wellbeing and cognitive performance; Diet and Nutrition - Other diet and nutrition disorders; Cardiovascular - Hypertension; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12616001046493
• Lead Sponsor: niversity of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Free-living non-smoking men and women, aged between 45-75 years with elevated SBP equal to or above 120mmHg (high-normal range) and not on antihypertensive medication,
who habitually consume 1 or less serves of fresh pork per week
WITH at least 2 risk factors for CVD:

1. overweight/obese with BMI equal to or above 25kg/m2
2. waist circumference men greater than94cm, women greater than 80cm
3. dyslipidemia one of the following: total cholesterol equal to or greater than 5.5mM, triglycerides equal to or greater than 2.0mM, LDL equal to or greater than 3.5, HDL men equal to or less than 0.9 women less than 1.0,
4. impaired glucose tolerance (fasted glucose between 6.1-7.8mmol/L)
5. Family history of CVD (MI or sudden death before 55yrs for men or 65yrs for female 1st degree relatives)
6. Family history of type 2 diabetes mellitus (T2DM)

Exclusion Criteria

1. Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol
2. Unable to consume pork
3. Previous/current traumatic head/brain injury, neurological or psychiatric conditions
4. Previous stroke
5. Use of anti-depressant, anxiety or neurological or psychiatric medication
6. Current or recent (in the last 6 months) malignancy
7. Major liver, kidney, respiratory, gastrointestinal disease
8. Current CVD or angina
9. Actively trying to lose weight
10. Pregnancy/lactating
11. Smoker (within the last 6months)
12. Diagnosed T2DM
13. Allergy/sensitivity to nuts, seafood, etc. relevant to the dietary protocol
14. Illegal drug use or alcoholism
15. Weight >135kg (DEXA limitations)
16. Diagnosis of Alzheimer’s Disease, dementia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure will be determined by automatic oscillatory using a Digital Blood Pressure Monitor. Volunteers will monitor blood pressure three times a day, at home, for 6 days generating 54 data points of blood pressure readings where the average will be taken.[Home measured blood pressure will be measured 6 days prior to baseline, during weeks 7-8, 15-16 and 23-24.]