Randomized crossover controlled clinical trial to assess the comparative acute effects of saturated fat rich meal (coconut fat and butter) with unsaturated fat rich meal (sesame oil) on vascular reactivity, blood pressure, plasma lipids and markers of insulin resistance in healthy adult men.
- Conditions
- Cardiovascular Disease
- Registration Number
- SLCTR/2022/016
- Lead Sponsor
- Wayamba University Research Grant (SRHDC/RP/04/19-05)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Study participants will be free from previously diagnosed chronic diseases such as diabetes, hypertension, dyslipidemia, heart diseases, cancers, liver and renal failure and Body Mass Index (BMI) between 18.5 to 27.0 kgm-2, no history of alcohol abuse (those who appear to binge drink or regular drink i.e. more than 15 units (1 unit =125 ml) of alcohol per week), not planning or on a weight reducing regime, not taking nutritional supplements (e.g. fish oil, calcium) and non-smokers.
Individuals with already diagnosed chronic diseases, anaemic people, people who are on antihypertensive, anti-diabetes or lipid lowering drugs, taking medication for inflammatory disease, such as arthritis, dermatitis, and hepatitis and BMI greater than 27 kgm-2 will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in vascular reactivity measured by pulse wave velocity (PWVc-f) using an oscillometric Mobil-O-Graph® PWA Monitor device (I.E.M GmbH, Stolberg, Germany) with integrated ARCSolver® software. [Time Frame: Acute study: measured at 0 (baseline), 180, and 300 min. ]<br>Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure and pulse pressure) using an oscillometric Mobil-O-Graph® PWA Monitor device (I.E.M GmbH, Stolberg, Germany) with integrated ARCSolver® software. [Time Frame: Acute study: measured at 0 (baseline), 180, and 300 min. ]<br> [ ]<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br>
- Secondary Outcome Measures
Name Time Method Change from baseline in plasma lipids (primarily triacylglycerol, total cholesterol, LDL and HDL cholesterol) [Time Frame: Acute study: taken at 60 min intervals between 0 min (baseline) and 360 min ]<br>Change from baseline in markers of insulin resistance (glucose, insulin, indices of insulin resistance/sensitivity)<br>Fasting insulin resistance and insulin sensitivity will be determined by HOMA-IR and the revised quantitative insulin sensitivity check index, respectively, with the use of standard equations (Brady et al, 2004). [Time Frame: Acute study: taken at 60 min intervals between 0 min (baseline) and 360 min ]<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> [ ]<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br> []<br>