Home » Trials » SLCTR/2022/016


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

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SLCTR Registration Number

SLCTR/2022/016


Date of Registration

29 Jun 2022

The date of last modification

Jun 29, 2022



Application Summary


Scientific Title of Trial

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


Public Title of Trial

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.


Disease or Health Condition(s) Studied

Cardiovascular Disease


Scientific Acronym

None


Public Acronym

None


Brief title

The acute effects of meals rich in saturated, and unsaturated fatty acids on vascular function and postprandial lipaemia


Universal Trial Number

U1111-1278-7446


Any other number(s) assigned to the trial and issuing authority

ERC/20-011


Trial Details


What is the research question being addressed?

What is the effect of meals rich in saturated fat (coconut fat and butter) compared to meals rich in unsaturated fat (sesame oil) on postprandial vascular reactivity, blood pressure, plasma lipids and markers of insulin resistance in healthy adult men?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Investigators, Outcome assessors


Control

Active


Assignment

Crossover


Purpose

Prevention


Study Phase

Not Applicable


Intervention(s) planned

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, Makandura (NWP), 60170. The study protocol will be conducted in accordance with the Declaration of Helsinki. The participants will be randomly allocated to the 3 different treatment arms with the use of a random-assignment programme (Available from: http://www.randomizer.org/). The study is cross-over trials and consists of 3 arms and are as follows: 1. Arm 1: A test meal consist of 50 g of total fat rich in saturated fat (coconut oil) 2. Arm 2: A test meal consist of 50 g of total fat rich in in saturated fat (butter) 3. Arm 3: A test meal consist of 50 g of total fat rich in in unsaturated fat (sesame) Three arms will be cross over 2 weeks apart. Each participant will receive 3 study meals after fasting overnight for 12 h on three different study days in random order, with approximately 2 weeks apart of each study visit. Each of the 3 postprandial visits, will last?7 h. Test meal will be provided in the form of a warm chocolate drink containing the specific test fat or oil accompanied by toasted thick white bread with strawberry jam. Each test meal will be assigned meal codes and the participant and researcher involved in the study will be unaware about the meal codes and the code will be kept under password protected.


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

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.



Primary outcome(s)

1.

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.

]
2.

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.

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Time Frame: Acute study: measured at 0 (baseline), 180, and 300 min.

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Secondary outcome(s)

1.

Change from baseline in plasma lipids (primarily triacylglycerol, total cholesterol, LDL and HDL cholesterol)

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Time Frame: Acute study: taken at 60 min intervals between 0 min (baseline) and 360 min

]
2.

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).

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Time Frame: Acute study: taken at 60 min intervals between 0 min (baseline) and 360 min

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Target number/sample size

15


Countries of recruitment

Sri Lanka


Anticipated start date

2022-06-30


Anticipated end date

2022-11-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Wayamba University Research Grant (SRHDC/RP/04/19-05)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2020-10-16


Approval number

ERC 20 - 011


Details of Ethics Review Committee

Name: Ethics Review Committee, Sri Lanka Medical Association
Institutional Address:Ethics review committee Sri Lanka Medical Association (SLMA) 6, Wijerama Mawatha Colombo 7
Telephone:+94(11) 269 3324
Email: erc.slma@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr Kumari M Rathnayake
Head/Senior Lecturer
Department of Applied Nutrition Wayamba University of Sri Lanka, Makandura (NWP), 60170
+94312298120
+94718129722

kumarimr@wyb.ac.lk
https://flfn.wyb.ac.lk/?page_id=1704

Contact Person for Public Queries

Dr Kumari M Rathnayake
Head/Senior Lecturer
Department of Applied Nutrition Wayamba University of Sri Lanka, Makandura (NWP), 60170
+94312298120
+94718129722

kumarimr@wyb.ac.lk
https://flfn.wyb.ac.lk/?page_id=1704


Primary study sponsor/organization

Wayamba University Research Grant (SRHDC/RP/04/19-05)

Chairman Senate Research and Higher Degrees committee, Wayamba University of Sri Lanka, Lionel Jayathilaka Mawatha, Kuliyapitiya, 60200 Sri Lanka
+(94) 37 22 81412, +(94) 37 22 81414

academicbranch@wyb.ac.lk
https://www.wyb.ac.lk/academic-division/

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Mean values of the Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be shared. Study protocol, statistical analysis plan will be made available. Data will be available immediately following publication and ending 5 years following article publication. Data will be made available to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims in an approved proposal and shared for the purpose of individual participant data meta analyses. Proposals should be directed to kumarimr@wyb.ac.lk. To gain access, data requestors will need to sign a data access agreement.


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results