Clinical trial NCT01369173: COMIDAS Comparing Original Mexican Diets and Standard US Diets
Official title: Metabolic Response to Western vs. Indigenous Diets in Hispanic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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

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 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.

Primary outcomes:
measure: metabolic response measured by blood concentrations of biomarkers
timeFrame: Change from Baseline at 24 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
References:
citation: Santiago-Torres M, De Dieu Tapsoba J, Kratz M, Lampe JW, Breymeyer KL, Levy L, Song X, Villasenor A, Wang CY, Fejerman L, Neuhouser ML, Carlson CS. Genetic ancestry in relation to the metabolic response to a US versus traditional Mexican diet: a randomized crossover feeding trial among women of Mexican descent. Eur J Clin Nutr. 2017 Mar;71(3):395-401. doi: 10.1038/ejcn.2016.211. Epub 2016 Dec 14.
citation: Santiago-Torres M, Kratz M, Lampe JW, Tapsoba Jde D, Breymeyer KL, Levy L, Villasenor A, Wang CY, Song X, Neuhouser ML. Metabolic responses to a traditional Mexican diet compared with a commonly consumed US diet in women of Mexican descent: a randomized crossover feeding trial. Am J Clin Nutr. 2016 Feb;103(2):366-74. doi: 10.3945/ajcn.115.119016. Epub 2015 Dec 30.