Home » Trials » SLCTR/2019/034


A sequential feeding trial of coconut oil versus palm oil on cardio-metabolic risk factors in healthy adults

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SLCTR Registration Number

SLCTR/2019/034


Date of Registration

04 Oct 2019

The date of last modification

Oct 04, 2019



Application Summary


Scientific Title of Trial

A sequential feeding trial of coconut oil versus palm oil on cardio-metabolic risk factors in healthy adults


Public Title of Trial

Comparing impact of coconut oil versus palm oil on selected cardiovascular disease risk factors in free-living healthy adults in households of a selected area in Colombo: single arm study


Disease or Health Condition(s) Studied

Cardiovascular disease risk


Scientific Acronym

None


Public Acronym

none


Brief title

A trial comparing coconut oil versus palm oil on cardio-metabolic risk factors


Universal Trial Number

U1111-1237-6417


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

EC-19-046


Trial Details


What is the research question being addressed?

Would coconut fat beneficially affect lipid profile and other cardio-metabolic risk factors compared to palm oil in healthy adults in Sri Lanka?


Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Double blinded : Participants, Investigators, Data analysts, Healthcare providers, Outcome assessors


Control

Active


Assignment

Sequential


Purpose

Other


Study Phase

Not Applicable


Intervention(s) planned

Study setting and participant recruitment

Experiment will be conducted in the community. This will be a voluntary recruitment and participants will be non-institutional adults. Healthy adults living at a permanent address within 10 km from the Faculty of Medicine, University of Colombo (Kynsey Road, Colombo 08) will be invited to participate in the study by advertisement.

Screening

Interested volunteers will be provided with an outline of the study. Socio-demography, general life style pattern, medical history and co-morbidities will be collected using a standard interviewer administered questionnaire. Potential participants will be identified and those who meet all the inclusion criteria will be screened using anthropometry, blood pressure and a blood sample will be drawn following their informed written consent. Using standard cut offs, those who have abnormal blood biochemistry will be excluded. Recruited participants will be visited at their homes for intervention and assessments.

Experimental design

The study period will be divided into two feeding periods of 8 weeks each, separated by a 4 week wash out period. Participants will be provided with one unlabeled test oil and instructed to use it only, and in place of their usual cooking oil for all their food preparation during the first 8 week feeding period. After 4 weeks of wash out period, the other unlabeled oil will be given for another 8 weeks. During the 4 week wash-out period in between the two testing phases, participants will be advised to use their usual oil with usual foods. Coconut oil and palm oil will be taken from one particular batch.

Dietary Intervention

(i) Assessing the individual daily amount of oil A baseline 24 hour dietary recall will be used to assess their dietary pattern. Participants will be fed on individualized calorie requirements and advised to follow their routine physical activity practices. Energy requirement will be calculated based on Harris Benedict principle. Ex: Daily calorie needs will be calculated as follows,
If participant is sedentary, calorie allowance is = BMR x 1.15 If light activity = BMR x 1.30 If moderate activity = BMR x 1.40
If very active = BMR x 1.50 If extremely active = BMR x 1.6. Screening body weight is used to calculate basal metabolic rate (BMR) to apply to Harris-Benedict equation. For Men: - BMR= 66+ [13.7 x weight (kg)] + [5 x height (cm)] - [6.8 x age (years)] For Women: - BMR= 655+ [9.6 x weight (kg)] + [1.8 x height (cm)] - [4.7 x age (years)] 10% of an individual’s total energy requirement will be supplied by the test oil. eg. ; for a 2000 kcal diet, at least 22g of treatment oil per day is required, and considering the specific gravity of coconut oil as 0.927, 24 ml of test oil will be considered the minimum quantity of oil to be taken by that person to achieve the desired effect in the outcomes of interest.

(ii) Incorporation of treatment oils to the meals
The entire household will be provided the test oil weekly in sealed containers during the period of study, with instructions on use. Consumption of the participant’s target oil volumes (dosage) will be ensured by: After the food has been prepared for the whole family, participants will be requested to use the measured volume of oil per day to temper only the portion of food to be consumed by the participant (measuring cups will be provided). Participants will maintain records of oil volumes used per meal which will be checked through home visits and telephone.

(iii) Supplying oil and monitoring the compliance Conducting food recalls and regular interviews on a bi-weekly basis with the study participants. A set of questions will be asked during the interview to address whether they took the minimum required oil volume on each day.


Inclusion criteria

  1. Free living healthy adults who take their meals at home.
    1. Both male and female between 18-60 years.

Exclusion criteria

  1. Those who have a medical history of cardiovascular diseases, stroke, thyroid disease, diabetes mellitus, liver or renal dysfunction (acute or chronic), peptic ulceration, cancer.
  2. Those who smoke or consume alcohol.
  3. Individuals taking any medications for dyslipidemia, hypercholesterolemia, or inflammatory disorders or patients receiving tetracycline therapy.
  4. Those who use herbal/ antioxidant or vitamin or mineral/omega 3 or omega 6 supplements.
    1. Those who follow weight loss regime, any prescribed diet or who frequently consume food from outside.
  5. Pregnant and lactating mothers.


Primary outcome(s)

1.

Difference in mean serum LDL-Cholesterol in the group between coconut feeding period and palm oil feeding period

[

Difference between baseline and end of 8 weeks of each feeding periods of both coconut and palm oil feedings.

]

Secondary outcome(s)

1.

The change in mean of the following variables within the group before and after coconut and palm oil consumption.

i. Serumtotal and high-density lipoprotein cholesterol (Total Cholesterol and HDL-C), TC/HDL-C ratio, Triglycerides, VLDs, hs-CRP, fasting plasma glucose, glycated haemoglobin (HbA1c), Apo A, Apo B,), ALT and AST

ii. Weight, body mass index (BMI), waist circumference, waist to hip ratio, changes in body composition

iii. Systolic and diastolic blood pressure

[

Difference between baseline and end of 8 weeks of each coconut and palm oil feeding periods.

]

Target number/sample size

40


Countries of recruitment

Sri Lanka


Anticipated start date

2020-01-01


Anticipated end date

2020-07-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

National Science Foundation (NSF)


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-07-25


Approval number

EC-19-046


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Colombo
Institutional Address:Ethics Review Committee of the Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 08, Sri Lanka
Telephone:0712106520/ 0112695300 (ext: 240)
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Ranil Jayawardena
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 08, Sri Lanka
94-112 695300 [ext: 203/204/205]
0718323332
011269748
ranil7@gmail.com / ranil@physiol.cmb.ac.lk

Contact Person for Public Queries

Ms.A.K.S. Hasinthi Swarnamali
Research Assistant
Health and Wellness Unit, Faculty of Medicine, University of Colombo, 25, Kynsey Road, Colombo 08, Sri Lanka

0777662877

shasinthi@yahoo.com


Primary study sponsor/organization

Prof. Ananda Jayawardane
Director General
National Science Foundation (NSF) 47/5, Maitland Place Colombo 07 Sri Lanka
+94 112694170
+94112694754
grants2019@nsf.gov.lk
www.nsf.gov.lk

Secondary study sponsor (If any)







Trial Completion details


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

No


IPD sharing plan description


Study protocol available

Yes


Protocol version and date

Version 3.0/ 18th July 2019


Protocol URL

N/A

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