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

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.

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

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.