Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233311
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2005-10-03
Brief Title:
Fast Food Study Assessment of the Effects of Fast-Food on Inflammatory Markers
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Assessment of the Postprandial Effects of a Fast-food on Inflammatory Markers
Status:
COMPLETED
Status Verified Date:
2012-08
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:
The purpose of this research study is to determine whether eating a fast food meal high in saturated fat will result in greater increases in inflammatory markers than eating a meal with low levels of saturated fat and higher levels of mono-unsaturated fat This study is a first step in learning about how dietary fat intake can directly impact risk factors for heart disease diabetes and obesity
Detailed Description:
At the first visit each potential participant will undergo the screening examination including laboratory tests An electrocardiogram ECG is performed at baseline to exclude participants with evidence of myocardial infarction Each participant will complete a Food Intake Record to assess typical dietary patterns Cognitive status will be assessed with the Mini-Mental Status Exam The potential participant must acknowledge his or her willingness to consume the two test meals designed for the study
During visits 2 and 3 the participant will undergo the Oral Glucose Tolerance Test The Fast Food and Healthy Meals will be administered during Visits 456 7 After fasting for at least 8 hours the participant will have an intravenous IV line placed in an arm vein Twenty minutes will be allotted for participants to complete each experimental meal either the fast food or healthy meal At the end of the 20 minutes blood will be collected through an intravenous port over an eight-hour time period Baseline blood samples will also be collected prior to each meal The two mixed meals will be 1 a fast-food meal equivalent to the Big Mac Meal with French fries and milkshake 2 a meal with the same fat distribution as the fast-food meal with fats derived from mono-unsaturated fat sources A registered dietitian will prepare both of the meals To prevent any carry-over effects from previous meals participants will be asked to fast overnight with their last meal being a light dinner no later 12 hours before scheduled testing In addition participants will be asked to avoid high fat high calorie meals during the course of the study Participants will be given specific dietary guidelines to follow during the course of the study and in the four days preceding the OGTT at visit 2 They will be asked to complete a diet diary so that their adherence to the dietary recommendations can be monitored All participants will be asked to continue with their normal exercise routine with the exception that no exercise is to be done in the 24 hours prior to each testing session During the OGTT and the testing sessions for the two meals an ECG will be continuously recorded using a Holter monitor
The primary study hypotheses are
Administration of the different meals different nutrient compositions will cause differential increases in the circulating levels of inflammatory markers Specifically the fast-food meal high in saturated fat will cause a greater increase in circulating inflammatory markers specifically C-reactive protein CRP than the oral glucose or the mono-unsaturated fat meal Also this difference in inflammatory response will not be explained by parallel changes in circulating lipid levels
The inflammatory response within an individual to the standard oral glucose tolerance test OGTT and to each meal is reproducible over a 48-hour period
The secondary hypothesis is
Changes in the serum level of glucose and insulin following a standard oral glucose tolerance test will predict changes in circulating levels of inflammatory markers after both meals
During visits 2 and 3 the participant will undergo the Oral Glucose Tolerance Test The Fast Food and Healthy Meals will be administered during Visits 456 7 After fasting for at least 8 hours the participant will have an intravenous IV line placed in an arm vein Twenty minutes will be allotted for participants to complete each experimental meal either the fast food or healthy meal At the end of the 20 minutes blood will be collected through an intravenous port over an eight-hour time period Baseline blood samples will also be collected prior to each meal The two mixed meals will be 1 a fast-food meal equivalent to the Big Mac Meal with French fries and milkshake 2 a meal with the same fat distribution as the fast-food meal with fats derived from mono-unsaturated fat sources A registered dietitian will prepare both of the meals To prevent any carry-over effects from previous meals participants will be asked to fast overnight with their last meal being a light dinner no later 12 hours before scheduled testing In addition participants will be asked to avoid high fat high calorie meals during the course of the study Participants will be given specific dietary guidelines to follow during the course of the study and in the four days preceding the OGTT at visit 2 They will be asked to complete a diet diary so that their adherence to the dietary recommendations can be monitored All participants will be asked to continue with their normal exercise routine with the exception that no exercise is to be done in the 24 hours prior to each testing session During the OGTT and the testing sessions for the two meals an ECG will be continuously recorded using a Holter monitor
The primary study hypotheses are
Administration of the different meals different nutrient compositions will cause differential increases in the circulating levels of inflammatory markers Specifically the fast-food meal high in saturated fat will cause a greater increase in circulating inflammatory markers specifically C-reactive protein CRP than the oral glucose or the mono-unsaturated fat meal Also this difference in inflammatory response will not be explained by parallel changes in circulating lipid levels
The inflammatory response within an individual to the standard oral glucose tolerance test OGTT and to each meal is reproducible over a 48-hour period
The secondary hypothesis is
Changes in the serum level of glucose and insulin following a standard oral glucose tolerance test will predict changes in circulating levels of inflammatory markers after both meals
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