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

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ClinicalTrials.gov Identifier: NCT01498848
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
ANA BAYLIN, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Compliance Dietary Supplement: Cooking oils Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia
Study Start Date : June 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Acceptability and Blindness [ Time Frame: 4 weeks ]
    We assessed acceptability and blindness of the cooking oil intervention by use of questionnaires


Eligibility Criteria
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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: ANA BAYLIN, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01498848     History of Changes
Other Study ID Numbers: HUM00048757
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013