Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120016
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2005-07-06
Brief Title:
Design and Feasibility of a Mediterranean Diet
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Design and Feasibility of a Mediterranean Diet
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 fruitvegetable 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 servingsday 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 US 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 fruitvegetable 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 PSM ratio of a typical American diet is about 101517 and the goal for this intervention diet will be 125 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 servingsday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03B043-REV | None | None | None |