Design and Feasibility of a Mediterranean Diet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zora Djuric, University of Michigan
ClinicalTrials.gov Identifier:
NCT00120016
First received: July 6, 2005
Last updated: December 19, 2012
Last verified: November 2008
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: dietary counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Design and Feasibility of a Mediterranean Diet

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • fatty acid intakes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • carotenoids intakes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • fatty acid ratios in blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • carotenoids in blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • cholesterol in blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • markers of oxidative stress in blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mediterranean diet
Behavioral: dietary counseling
telephone counseling
Other Name: high MUFA diet
No Intervention: 2
non-intervention diet

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120016

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Zora Djuric, PhD University of Michigan
  More Information

Publications:
Responsible Party: Zora Djuric, Research Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00120016     History of Changes
Other Study ID Numbers: 051517, 03B043-REV
Study First Received: July 6, 2005
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
cancer prevention
diet
nutrition
polyunsaturated fat
olive oil

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014