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.

The chronic and acute effects of different saturated or unsaturated fatty acids on vascular function, blood pressure and cardiometabolic risk markers in healthy adult men

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2022/016

Enrollment

Registered

2022-06-29

Start date

2022-06-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Interventions

This study will be conducted at the Clinical laboratory and the study meals will be prepared at the dietetic laboratory of the Department of Applied Nutrition, Wayamba University of Sri Lanka, Makandu

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. ] 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. ]	—

Measure

Time frame

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. ] 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. ]

—

Secondary

Measure	Time frame
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 ] Change from baseline in markers of insulin resistance (glucose, insulin, indices of insulin resistance/sensitivity) 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 ]	—

Measure

Time frame

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 ] Change from baseline in markers of insulin resistance (glucose, insulin, indices of insulin resistance/sensitivity) 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 ]

—

Countries

Sri Lanka

Contacts

Public ContactDr Kumari M Rathnayake

Head/Senior Lecturer

kumarimr@wyb.ac.lk+94312298120

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026