Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia

Study Overview
=================
Brief Summary
-----------------
We conducted a randomized trial to determine the effect of providing families from Bogota, Colombia, with a one month supply of one of two cooking oils, sunflower oil vs. soybean oil, on whole blood and saliva fatty acid composition of children. The aims were: 1) assess the effect of the oils on whole blood fatty acid composition in children, 2) assess the correlation between whole blood and saliva to evaluate if fatty acids measured in saliva would be adequate biomarkers of intake. The study was conducted in the context of an ongoing cohort study of school children from Bogotá, Colombia (HUM00043252). We conducted an intervention trial of 4 week duration. Participant families were randomly assigned to either sunflower oil or soybean oil. Families were visited two times during the 4 week period. We collected dietary information from the person in the household in charge of food preparation, and from the child. At the end of the intervention we collected information on whether or not they liked the oil and whether they would be willing to use it, exclusively, for two years, to assess acceptability for a longer intervention. We also collected two finger prick blood samples and two saliva/cheek cells samples from the child, at the beginning and at the end of the study, to evaluate compliance and to assess the impact of the intervention.

Detailed Description
-----------------
We conducted a randomized trial to determine the effect of providing families from Bogota, Colombia, with a one month supply of one of two cooking oils, sunflower oil vs. soybean oil, on whole blood and saliva fatty acid composition of children. The aims were: 1) assess the effect of the oils on whole blood fatty acid composition in children, 2) assess the correlation between whole blood and saliva to evaluate if fatty acids measured in saliva would be adequate biomarkers of intake. The study was conducted in the context of an ongoing cohort study of school children from Bogotá, Colombia (HUM00043252). We conducted an intervention trial of 4 week duration. Participant families were randomly assigned to either sunflower oil or soybean oil. Families were visited two times during the 4 week period. We collected dietary information from the person in the household in charge of food preparation, and from the child. At the end of the intervention we collected information on whether or not they liked the oil and whether they would be willing to use it, exclusively, for two years, to assess acceptability for a longer intervention. We also collected two finger prick blood samples and two saliva/cheek cells samples from the child, at the beginning and at the end of the study, to evaluate compliance and to assess the impact of the intervention.

Official Title
-----------------
Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia

Conditions
-----------------
Compliance

Intervention / Treatment
-----------------
* Dietary Supplement: Cooking oils


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a participant in the ongoing Bogota School Children cohort Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soybean oil<br>Families were given soybean oil for cooking during 4 weeks | Dietary Supplement: Cooking oils<br>* Families were randomized to receive either soybean or sunflower oil for cooking during 4 weeks<br>|
| Active Comparator: Sunflower oil<br>Families were given sunflower oil for cooking during 4 weeks | Dietary Supplement: Cooking oils<br>* Families were randomized to receive either soybean or sunflower oil for cooking during 4 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the intervention on whole blood and saliva fatty acid composition | We measured fatty acids in blood to assess effectiveness of the intervention. We measured fatty acids in saliva to evaluate if they can be good biomarkers of intake. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and Blindness | We assessed acceptability and blindness of the cooking oil intervention by use of questionnaires | 4 weeks |