NCT01369173

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

June 3, 2011

Last Update Submit

May 4, 2015

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • metabolic response measured by blood concentrations of biomarkers

    Participants will have a blood draw at the beginning and end of each intervention arm.

    Change from Baseline at 24 days

Study Arms (2)

Mexican Menu

ACTIVE COMPARATOR

24 days, all foods and drinks provided, menu consists of traditional mexican meals

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

Other: Mexican or American foods

Interventions

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.

Mexican MenuUS diet

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98133, United States

Location

Related Publications (2)

  • 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.

    PMID: 27966572DERIVED

  • 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.

    PMID: 26718418DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 8, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2014

Study Completion

April 1, 2015

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

US(1)