MedTrace Logo

COMIDAS Comparing Original Mexican Diets and Standard US Diets

NCT01369173 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-05-06

No results posted yet for this study

Summary

The foods eaten daily are considered the "dietary pattern" of a culture or country. The dietary pattern of Mexico is different from that of the United States. To look at the effects of these patterns, participants in this study eat a Mexican menu for three and a half weeks and an American menu for the same length of time. At the beginning and end of each menu period participants provide blood and urine samples which we analyze to compare the effects of each diet. More info at www.ProyectoCOMIDAS.info

Conditions

  • Healthy

Interventions

OTHER

Mexican or American foods

Participants will be randomized to an isocaloric Indigenous Mexican or a Western diet for 24 days. All foods and beverages will be prepared by the Human Nutrition Laboratory at the Fred Hutchinson Cancer Research Center. After a 4-week wash-out period, participants will cross over to the other arm and be given the alternate diet for 24 days. Blood and urine specimens will be collected before and after each feeding period to test baseline and post-intervention metabolic response as defined by various inflammatory and cancer susceptibility biomarkers including insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein 3 (IGFBP3), leptin, adiponectin, interleukin-6 (IL-6), C-reactive protein (CRP) and SAA (serum amyloid-A). DNA extracted from whole blood will be used to test whether a panel of 128 Ancestry Informative Markers (AIMs) is associated with metabolic response to the diets and other phenotypic traits of obesity, which relate to breast cancer risk.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-08-31
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369173 on ClinicalTrials.gov