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

Purpose

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.

Condition	Intervention
Compliance	Dietary Supplement: Cooking oils


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Prevention
Official Title:	Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia

Further study details as provided by ANA BAYLIN, University of Michigan:

Primary Outcome Measures:

Effect of the intervention on whole blood and saliva fatty acid composition [ Time Frame: 4 weeks ]
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.

Secondary Outcome Measures:

Acceptability and Blindness [ Time Frame: 4 weeks ]
We assessed acceptability and blindness of the cooking oil intervention by use of questionnaires


Enrollment:	60
Study Start Date:	June 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Soybean oil Families were given soybean oil for cooking during 4 weeks	Dietary Supplement: Cooking oils Families were randomized to receive either soybean or sunflower oil for cooking during 4 weeks
Active Comparator: Sunflower oil Families were given sunflower oil for cooking during 4 weeks	Dietary Supplement: Cooking oils Families were randomized to receive either soybean or sunflower oil for cooking during 4 weeks

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.

Eligibility


Ages Eligible for Study:	10 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Being a participant in the ongoing Bogota School Children cohort

Exclusion Criteria:

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01498848

Locations


Colombia
Universidad Pontificia Javeriana
Bogota, Colombia

Sponsors and Collaborators

University of Michigan

Investigators


Principal Investigator:	Ana Baylin, MD, DrPH	University of Michigan

More Information


Responsible Party:	ANA BAYLIN, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier:	NCT01498848 History of Changes
Other Study ID Numbers:	HUM00048757
Study First Received:	December 21, 2011
Last Updated:	June 18, 2013

ClinicalTrials.gov processed this record on June 28, 2017