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

NCT01498848 | Completed

• 1 other identifier: HUM00048757
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Compliance

Outcome Measures

Primary Outcomes (1)

• Effect of the intervention on whole blood and saliva fatty acid composition

  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.

  4 weeks

Secondary Outcomes (1)

• Acceptability and Blindness

  4 weeks

Study Arms (2)

Soybean oil

ACTIVE COMPARATOR

Families were given soybean oil for cooking during 4 weeks

Dietary Supplement: Cooking oils

Sunflower oil

ACTIVE COMPARATOR

Families were given sunflower oil for cooking during 4 weeks

Dietary Supplement: Cooking oils

Interventions

Cooking oils DIETARY_SUPPLEMENT

Families were randomized to receive either soybean or sunflower oil for cooking during 4 weeks

Soybean oil; Sunflower oil

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a participant in the ongoing Bogota School Children cohort

You may not qualify if:

• None

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Universidad Pontificia Javeriana

Bogotá, Colombia

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ana Baylin, MD, DrPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

CO (1)