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Design and Feasibility of a Mediterranean Diet

25 Years
65 Years
Not Enrolling
Breast Cancer

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Trial Information

Design and Feasibility of a Mediterranean Diet

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

fatty acid intakes

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Zora Djuric, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:




Start Date:

January 2004

Completion Date:

June 2007

Related Keywords:

  • Breast Cancer
  • cancer prevention
  • diet
  • nutrition
  • polyunsaturated fat
  • olive oil
  • Breast Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624