Design and Feasibility of a Mediterranean Diet

NCT ID: NCT00120016

Last Updated: 2012-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2007-06-30

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.

Detailed Description

It has been difficult to identify specific nutrients or food groups associated with breast cancer risk from epidemiological studies done in the U.S. Attention is now turning to the importance of overall eating patterns. A Greek-Mediterranean dietary pattern has great potential for cancer prevention. Two distinct aspects of this eating pattern are the type of fat consumed and a high fruit/vegetable intake relative to average intakes in the United States. We propose to develop and test an exchange list Greek-Mediterranean diet that could be used in future clinical trials of breast cancer prevention in women at increased risk. In this proposed study, women will be randomized to either continue their own usual diet or follow an intervention diet for 6 months. The intervention diet will be designed to decrease polyunsaturated (P) and saturated (S) fat intakes while increasing monounsaturated (M) fat intake. The P:S:M ratio of a typical American diet is about 1.0:1.5:1.7, and the goal for this intervention diet will be 1:2:5, which is much closer to that of the traditional Greek diet. A predominant source of fat will be olive oil. The fruit and vegetable goal will be 7-9 servings/day, depending on energy intake. These dietary changes will be achieved using individualized telephone counseling and a monthly group session with a dietitian. Menus will be provided as examples, but the diets will be self-selected. Compliance to the dietary goals will be assessed by food records and levels of plasma fatty acids, lipids and carotenoids. As a feasibility investigation for the planning of larger trials, plasma 8-isoprostane, oxidized lycopene, insulin and glucose levels will also be assessed since these may lend insight into two possible mechanisms that may be responsible for the cancer preventive effects of this diet. 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. This intervention approach can then be tested for its effects on markers of breast cancer risk in future studies.

Conditions

Breast Cancer

Keywords

cancer prevention; diet; nutrition; polyunsaturated fat; olive oil

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Mediterranean diet

Group Type: EXPERIMENTAL

dietary counseling

Intervention Type: BEHAVIORAL

telephone counseling

2

non-intervention diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

dietary counseling

telephone counseling

Intervention Type: BEHAVIORAL

Other Intervention Names

high MUFA diet

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Zora Djuric

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zora Djuric, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19358929 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19027409 (View on PubMed)

Other Identifiers

03B043-REV

Identifier Type: -

Identifier Source: secondary_id

051517

Identifier Type: -

Identifier Source: org_study_id