Fast Food Study: Assessment of the Effects of Fast-Food on Inflammatory Markers

Completed

Conditions studied: Heart Diseases, Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT00233311

Run by

National Institute on Aging (NIA)

People needed

61

Starts

2004-03-01

Expected to finish

2012-08-01

Last updated by the study team

2012-08-06

Who can join

Age: 50 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women between the ages of 50 and 65
• Body mass index (BMI) less than or equal to 30 kg/m2
• Waist circumference less than or equal to 40 inches for men and 35 inches for women (measured at natural waist just above the navel)
• CRP (C-reactive protein) level less than 3mg/L
• Report no difficulties or need for help in performing self care or instrumental activities of daily living
• Able to walk for at least 10 minutes without needing to stop or without symptom onset
• No substantial cognitive impairment based on mental status screening tests (score <24 on Mini-Mental Status Exam)
• No history of a cardiovascular event over the last three months (including angina, myocardial infarction, coronary artery bypass graft surgery (CABG), congestive heart failure, cerebro-vascular diseases), cancer, diabetes mellitus, neurological disease, thyroid disease, birth defect, kidney or liver disease, gastrointestinal (G.I.) diseases (including gallbladder disease), musculoskeletal disorder (if they cause pathological weakness and/or chronic pain), or important sensory deficits.

You may not qualify if…

• Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than or equal to 95 mmHg with or without treatment
• ECG shows evidence of myocardial infarction
• Abnormal laboratory tests
• Abnormal liver function
• Shortness of breath while performing normal activities of daily living, such as walking or climbing stairs
• Use of any hormones (i.e. estrogen, testosterone)
• Absolute need for long-term treatment with anti-inflammatories, aspirin (>100 mg per day per physician orders), statins, antibiotics, corticosteroids, immunosuppressors, H2 blockers and pain medications. Non-steroid anti-inflammatory use is allowed, but should be stopped three days before the study)
• Use of herbal supplements are not permitted during the study (Multivitamin is permitted, but other vitamin supplementation are not permitted during the study.)
• Any medication/drug that acts on lipid metabolism (i.e. Xenical)
• Any severe psychiatric condition
• Any infections requiring use of antibiotics within the past 3 months
• Current use of tobacco products
• Alcoholic intake > 30 grams while on this study is not permitted (no more than 2 beers per day or more than one glass of wine or cocktail daily)
• Intense physical activity over the past year (>6 metabolic equivalents [METs], at least 1 hour per week)
• Allergies to nuts
• Loss or gain of greater than or equal to 4 pounds in the past 6 months
• Any condition that may preclude informed consent
• Recent blood donation (past 3 months)

Where it is running

• NIA Clinical Research Unit at Harbor Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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