NCT00120016

Brief Summary

Epidemiological observations indicate that a Greek-Mediterranean dietary pattern has great potential for cancer prevention, but more definitive data on the preventive effects of this diet are needed. Two distinct aspects of this eating pattern are the type of fat consumed and a high fruit/vegetable intake. If the diet is feasible, it could be used in future clinical trials of breast cancer prevention. In this study, women randomly receive either a control diet or an intervention diet for 6 months. The intervention diet replaces half of the typical American fat intake with foods such as olive oil and nuts. The fruit and vegetable goal is 7-9 servings/day and includes several categories of fruits, vegetables, and herbs. Blood samples are drawn and analyzed for fatty acids derived from fats, micronutrients from fruits and vegetables, and markers of oxidative stress. This dietary trial will provide important data on the ability of women following typical American eating patterns to change their dietary intakes to reflect a Greek-Mediterranean pattern.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable breast-cancer

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

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

December 20, 2012

Status Verified

November 1, 2008

Enrollment Period

3.4 years

First QC Date

July 6, 2005

Last Update Submit

December 19, 2012

Conditions

Breast Cancer

Keywords

cancer preventiondietnutritionpolyunsaturated fatolive oil

Outcome Measures

Primary Outcomes (5)

  • fatty acid intakes

    6 months

  • carotenoids intakes

    6 months

  • fatty acid ratios in blood

    6 months

  • carotenoids in blood

    6 months

  • cholesterol in blood

    6 months

Secondary Outcomes (1)

  • markers of oxidative stress in blood

    6 months

Study Arms (2)

1

EXPERIMENTAL

Mediterranean diet

Behavioral: dietary counseling

2

NO INTERVENTION

non-intervention diet

Interventions

dietary counselingBEHAVIORAL

telephone counseling

Also known as: high MUFA diet
1

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good health
  • Normal weight
  • Age 25-65
  • Monounsaturated fat intake less than 48% of total fat
  • Fruit and vegetable intake less than 5.5 servings/day
  • Total fat intake more than 23% of energy

You may not qualify if:

  • High blood pressure
  • Obese
  • Pregnant or lactating
  • On medically prescribed diets
  • Taking supplements that obscure the effects of diet
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • Djuric Z, Ren J, Blythe J, VanLoon G, Sen A. A Mediterranean dietary intervention in healthy American women changes plasma carotenoids and fatty acids in distinct clusters. Nutr Res. 2009 Mar;29(3):156-63. doi: 10.1016/j.nutres.2009.03.001.

    PMID: 19358929RESULT

  • Djuric Z, Vanloon G, Radakovich K, Dilaura NM, Heilbrun LK, Sen A. Design of a Mediterranean exchange list diet implemented by telephone counseling. J Am Diet Assoc. 2008 Dec;108(12):2059-65. doi: 10.1016/j.jada.2008.09.006.

    PMID: 19027409RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Zora Djuric, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

January 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 20, 2012

Record last verified: 2008-11

Locations

US(1)