Fast Food Study: Assessment of the Effects of Fast-Food on Inflammatory Markers
Condition: Heart Diseases; Diabetes; Obesity
MeSH terms: Heart Diseases
Study type: Observational

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 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
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        General Public
      
Biospecimen description: 
      Serum, Whole Blood
    
Keywords: high fat diet; inflammation; inflammatory markers; C-reactive protein; Aging