Design and Feasibility of a Mediterranean Diet

Tracking Information
First Submitted Date ICMJE	July 6, 2005
First Posted Date ICMJE	July 14, 2005
Last Update Posted Date	December 20, 2012
Study Start Date ICMJE	January 2004
Actual Primary Completion Date	June 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 24, 2007)	fatty acid intakes [ Time Frame: 6 months ]; carotenoids intakes [ Time Frame: 6 months ]; fatty acid ratios in blood [ Time Frame: 6 months ]; carotenoids in blood [ Time Frame: 6 months ]; cholesterol in blood [ Time Frame: 6 months ]
Original Primary Outcome Measures ICMJE; (submitted: July 6, 2005)	fatty acid intakes; carotenoids intakes; fatty acid ratios in blood; carotenoids in blood; cholesterol in blood
Change History	Complete list of historical versions of study NCT00120016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 24, 2007)	markers of oxidative stress in blood [ Time Frame: 6 months ]
Original Secondary Outcome Measures ICMJE; (submitted: July 6, 2005)	markers of oxidative stress in blood
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Design and Feasibility of a Mediterranean Diet
Official Title ICMJE	Design and Feasibility of a Mediterranean Diet
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Breast Cancer
Intervention ICMJE	Behavioral: dietary counseling; telephone counseling; Other Name: high MUFA diet
Study Arms	Experimental: 1 Mediterranean diet Intervention: Behavioral: dietary counseling; No Intervention: 2 non-intervention diet
Publications *	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 6, 2005)	80
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2007
Actual Primary Completion Date	June 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	25 Years to 65 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00120016
Other Study ID Numbers ICMJE	051517; 03B043-REV
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Zora Djuric, University of Michigan
Study Sponsor ICMJE	University of Michigan
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Zora Djuric, PhD University of Michigan
PRS Account	University of Michigan
Verification Date	November 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP