COMIDAS Comparing Original Mexican Diets and Standard US Diets

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01369173
First received: June 3, 2011
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Healthy
Other: Mexican or American foods

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Metabolic Response to Western vs. Indigenous Diets in Hispanic Women

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • metabolic response measured by blood concentrations of biomarkers [ Time Frame: Change from Baseline at 24 days ] [ Designated as safety issue: No ]
    Participants will have a blood draw at the beginning and end of each intervention arm.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mexican Menu
24 days, all foods and drinks provided, menu consists of traditional mexican meals
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.
Active Comparator: US diet
24 days, all foods and drinks provided, menu consists of foods commonly eaten in contemporary United States
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.

Detailed Description:

Chronic disease risk, including breast cancer risk, is not uniform across race and ethnic groups in the United States. This variation in disease risk may be due to environmental exposures (including diet), genetic susceptibility, disparities in access to health screening, diagnosis and medical care, or combination of these factors. Here we have shown that Hispanic women in the U.S. are more likely to be overweight or obese compared to non-Hispanic whites. Some of the excess obesity risk is likely due to the lack of neighborhood availability and affordability of fruit, vegetables, lean protein and whole grains. Whether an inexpensive and widely available highly processed/refined, nutrient poor diet superimposed on a genetic background favoring adipose deposition (i.e., the "thrifty genotype") is metabolically detrimental has not been investigated. Research to test the metabolic response to Indigenous and Western diets in Hispanic women may provide important information about the etiology of obesity and obesity-related diseases in Hispanic women, including risk of breast cancer. Since reducing disparities in obesity-related diseases, including breast cancer, is an important public health goal, identifying potential programs for prevention should receive high priority.

Mexicans are the largest immigrant group in the United States with an estimated 10 million Mexican-American women currently in the U.S. As they acculturate to this country, Mexican immigrants change their dietary habits from traditional (indigenous) foods with plentiful fruit, vegetables and complex carbohydrates rich in fiber and other compounds to a Western-style diet high in fat and refined carbohydrate, but low in plant foods. Particularly concerning is that the food choices made by Mexican immigrants, many of whom are of lower socio-economic status, are driven partly by their inability to procure and purchase healthy foods. The disparity in both food availability and purchasing power fuels a tendency to obtain and consume a low-cost, Western style diet. When this diet is superimposed on persons with a "thrifty genotype" who are evolutionarily adapted to diets high in legumes and complex carbohydrates, it may lead to an abnormal metabolic response that favors adipose deposition and numerous health risks. Thus, ancestral genetic characteristics likely have an important role in metabolic response to specific dietary patterns and subsequent health risks. This phenomenon may partly explain the tendency for Mexicans and other immigrants from the Americas to become obese after just one generation in the United States.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Women of Mexican Descent
  • Age between 18-45 years

Exclusion Criteria:

  1. current physician-diagnosed diseases that require dietary restrictions or certain medications, including but not limited to, diabetes mellitus, kidney disease, other metabolic disorders, and cardiovascular disease requiring diet modifications
  2. impaired glucose tolerance defined as fasting glucose > 100 mg/dL; all participants will complete a fasting blood glucose determination
  3. BMI < 18.5 kg/m2 or > 40.0 kg/m2
  4. current pregnancy or pregnancy in last year, lactation or plans to become pregnant during the study period
  5. cessation of menses (either natural or surgical)
  6. any previous cancer diagnosis or treatment within the previous five years (excluding non-melanomatous skin cancer)
  7. restrained eating habits
  8. current use of tobacco (any smoking) or alcohol (> 2 drinks/day)
  9. inability (e.g., food allergy/intolerances) or unwillingness to consume the study foods.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369173

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98133
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01369173     History of Changes
Other Study ID Numbers: FHCRC IR 7099, P50CA148143
Study First Received: June 3, 2011
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
Healthy

ClinicalTrials.gov processed this record on September 16, 2014