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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
History of Changes

July 6, 2005
December 19, 2012
January 2004
June 2007   (final data collection date for primary outcome measure)
  • 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 ]
  • fatty acid intakes
  • carotenoids intakes
  • fatty acid ratios in blood
  • carotenoids in blood
  • cholesterol in blood
Complete list of historical versions of study NCT00120016 on ClinicalTrials.gov Archive Site
markers of oxidative stress in blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]
markers of oxidative stress in blood
Not Provided
Not Provided
 
Design and Feasibility of a Mediterranean Diet
Design and Feasibility of a Mediterranean Diet
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
Behavioral: dietary counseling
telephone counseling
Other Name: high MUFA diet
  • Experimental: 1
    Mediterranean diet
    Intervention: Behavioral: dietary counseling
  • No Intervention: 2
    non-intervention diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Female
25 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120016
051517, 03B043-REV
Yes
Not Provided
Not Provided
Zora Djuric, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Zora Djuric, PhD University of Michigan
University of Michigan
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP