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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01498848
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 29.9

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

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

Primary Outcome Measures

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

   We assessed acceptability and blindness of the cooking oil intervention by use of questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Being a participant in the ongoing Bogota School Children cohort

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Pontificia Javeriana	Bogota		Colombia

Sponsors and Collaborators

• University of Michigan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ANA BAYLIN, Associate Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01498848
• Other Study ID Numbers: HUM00048757
• First Posted: Dec 23, 2011
• Last Update Posted: Jun 19, 2013
• Last Verified: Jun 1, 2013

Study Results

No Results Posted as of Jun 19, 2013