Fast Food Study: Assessment of the Effects of Fast-Food on Inflammatory Markers
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of the Postprandial Effects of a Fast-food on Inflammatory Markers|
|Study Start Date:||March 2004|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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 4,5,6 & 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233311
|United States, Maryland|
|NIA Clinical Research Unit at Harbor Hospital|
|Baltimore, Maryland, United States, 21225|
|Principal Investigator:||Luigi Ferrucci, MD, PhD||MedStar Research Institute, NIA/Astra Unit, National Institute on Aging|