Status:
COMPLETED
Fast Food Study: Assessment of the Effects of Fast-Food on Inflammatory Markers
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Heart Diseases
Diabetes
Eligibility:
All Genders
50-65 years
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 o...
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 evid...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00233311
Start Date
March 1 2004
End Date
August 1 2012
Last Update
August 6 2012
Active Locations (1)
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1
NIA Clinical Research Unit at Harbor Hospital
Baltimore, Maryland, United States, 21225