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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ANA BAYLIN, University of Michigan
ClinicalTrials.gov Identifier:
NCT01498848
First received: December 21, 2011
Last updated: June 18, 2013
Last verified: June 2013
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Cooking Oils on Whole Blood and Saliva Fatty Acids in Children in Bogota, Colombia

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Effect of the intervention on whole blood and saliva fatty acid composition [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being a participant in the ongoing Bogota School Children cohort

Exclusion Criteria:

  • None
  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

No publications provided

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
Health Authority: United States: Institutional Review Board
Colombia: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014