HealthyCOMIDASNCT01369173
COMIDAS Comparing Original Mexican Diets and Standard US Diets
A study testing Mexican or American foods in people with Healthy, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mexican or American foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Women of Mexican Descent
- Age between 18-45 years
Who cannot join
- 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
- impaired glucose tolerance defined as fasting glucose > 100 mg/dL; all participants will complete a fasting blood glucose determination
- BMI < 18.5 kg/m2 or > 40.0 kg/m2
- current pregnancy or pregnancy in last year, lactation or plans to become pregnant during the study period
- cessation of menses (either natural or surgical)
- any previous cancer diagnosis or treatment within the previous five years (excluding non-melanomatous skin cancer)
Show all 9Show fewer
- restrained eating habits
- current use of tobacco (any smoking) or alcohol (> 2 drinks/day)
- inability (e.g., food allergy/intolerances) or unwillingness to consume the study foods.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98133
About this study
Official title: Metabolic Response to Western vs. Indigenous Diets in Hispanic Women
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
Read the 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.
- Conditions
- Healthy
- Being tested
- Mexican or American foods
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mexican or American foodsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mexican Menu | Active comparator | 24 days, all foods and drinks provided, menu consists of traditional mexican meals Receives: Other: Mexican or American foods |
| US diet | Active comparator | 24 days, all foods and drinks provided, menu consists of foods commonly eaten in contemporary United States Receives: Other: Mexican or American foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic response measured by blood concentrations of biomarkers
Participants will have a blood draw at the beginning and end of each intervention arm.
Measured: Change from Baseline at 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369173
- Sponsor's protocol ID
- FHCRC IR 7099
- Other IDs
- P50CA148143
- Acronym
- COMIDAS
- Status last verified
- May 2015
- First submitted
- 3 Jun 2011
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27966572Santiago-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.
PubMed 26718418
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Response to Western vs. Indigenous Diets in Hispanic Women
- ClinicalTrials.gov ID
- NCT01369173
- Acronym / sponsor ID
- COMIDAS / FHCRC IR 7099
- Conditions
- Healthy
- Keywords
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mexican Menu | Active comparator | Other: Mexican or American foods24 days, all foods and drinks provided, menu consists of traditional mexican meals |
| US diet | Active comparator | Other: Mexican or American foods24 days, all foods and drinks provided, menu consists of foods commonly eaten in contemporary United States |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Women of Mexican Descent
- Age between 18-45 years
Key exclusion criteria (9 listed)
- 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
- impaired glucose tolerance defined as fasting glucose > 100 mg/dL; all participants will complete a fasting blood glucose determination
- BMI < 18.5 kg/m2 or > 40.0 kg/m2
- current pregnancy or pregnancy in last year, lactation or plans to become pregnant during the study period
- cessation of menses (either natural or surgical)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mexican or American foodsParticipants 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. | Other | Mexican Menu, US diet |
Primary outcome
metabolic response measured by blood concentrations of biomarkers
Time frame: Change from Baseline at 24 days
Participants will have a blood draw at the beginning and end of each intervention arm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Derived from this study: PubMed 27966572Santiago-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.
- Derived from this study: PubMed 26718418Santiago-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mexican or American foods in people with Healthy, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic response measured by blood concentrations of biomarkers (time frame: Change from Baseline at 24 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01369173, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.