Clinical trial NCT01498848: Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia
Official title: Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Being a participant in the ongoing Bogota School Children cohort

Exclusion Criteria:

* None

Primary outcomes:
measure: Effect of the intervention on whole blood and saliva fatty acid composition
timeFrame: 4 weeks
Secondary outcomes:
measure: Acceptability and Blindness
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Universidad Pontificia Javeriana
Study officials:
affiliation: University of Michigan
name: Ana Baylin, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
References: