- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120016
Design and Feasibility of a Mediterranean Diet
December 19, 2012 updated by: Zora Djuric, University of Michigan
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.
Study Overview
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
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Mediterranean diet
|
telephone counseling
Other Names:
|
No Intervention: 2
non-intervention diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fatty acid intakes
Time Frame: 6 months
|
6 months
|
carotenoids intakes
Time Frame: 6 months
|
6 months
|
fatty acid ratios in blood
Time Frame: 6 months
|
6 months
|
carotenoids in blood
Time Frame: 6 months
|
6 months
|
cholesterol in blood
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
markers of oxidative stress in blood
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zora Djuric, PhD, University of Michigan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
July 6, 2005
First Submitted That Met QC Criteria
July 6, 2005
First Posted (Estimate)
July 14, 2005
Study Record Updates
Last Update Posted (Estimate)
December 20, 2012
Last Update Submitted That Met QC Criteria
December 19, 2012
Last Verified
November 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- 051517
- 03B043-REV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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