Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults
Completed · Not applicable
Conditions studied: Systemic Proinflammatory State
In brief
The purpose of this study is to investigate the effect of mineralocorticoid receptor (MR) blockade in healthy participants in a systemic proinflammatory state after a meal high in fat and glucose, which is associated with the pathogenesis of atherosclerosis. Participants will include normal-weight, healthy males (Body Mass Index (BMI) ≤ 25 kg/m\^2) between the ages of 18-45, without hypertension and clinical evidence of metabolic, cardiovascular or any other kind of diseases. After a 12-hour (h) fast, participants will be assigned to a combination of oral fat-loading test (OFLT) and oral glucose tolerance test (OGTT) (day 1), followed by a two-week treatment with 50 mg eplerenone. After two weeks, participants will receive the second OFLT/OGTT treatment (day 15). Starting 5 days prior to the first intervention (day1), the participant's usual diet (ad lib) will be supplemented with 2 bullion broths each day. Standardization of sodium intake is necessary as variations in dietary sodium intake may affect outcome measures. We will evaluate the following parameters at day 1 and day 15 of the study. Prior to OFLT/OGTT, and 2h, 4h thereafter, we will measure a parameter of vascular and systemic inflammation: interleukin-6 (IL-6).
Key facts
- Study ID
- NCT01786551
- Run by
- Brigham and Women's Hospital
- People needed
- 16
- Starts
- 2010-03-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2017-05-17
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- male
- 18-45 years
- BMI between 20-25 kg/m\^2
You may not qualify if…
- evidence of cardiovascular, hepatic, renal [estimated glomerular filtration rate (GFR) <60 millimeter/minute (ml/min)] or any other organ system disease
- Blood pressure equal to or less than 90/60 mmHg
- prescription or herbal medications
- smoking
- alcohol consumption of more than 2 drinks per day
- dietary supplements
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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