Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

Not Applicable

Completed

Brief Summary: 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).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Eplerenone	Eplerenone	Eplerenone 50 mg daily for 14 days

Primary Outcome Measures

Name	Time	Method
Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels	Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment	At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.

Secondary Outcome Measures

Name	Time	Method
Post-prandial Glucose Serum Levels	Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment	At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.
Post-prandial Insulin Serum Levels	Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment	At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.