Design and Feasibility of a Mediterranean Diet

Breast Cancer Clinical Trial

Official title:

Design and Feasibility of a Mediterranean Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120016
• Other study ID #: 051517
• Secondary ID: 03B043-REV
• Status: Completed
• Phase: N/A
• First received: July 6, 2005
• Last updated: December 19, 2012
• Start date: January 2004
• Est. completion date: June 2007

Study information

• Verified date: November 2008
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• dietary counseling
telephone counseling

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatty acid intakes		6 months	No
Primary	carotenoids intakes		6 months	No
Primary	fatty acid ratios in blood		6 months	No
Primary	carotenoids in blood		6 months	No
Primary	cholesterol in blood		6 months	No
Secondary	markers of oxidative stress in blood		6 months	No