Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

Mass General Brigham

Status: Completed

Conditions: Systemic Proinflammatory State

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT01786551

2010P002191

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male
• 18-45 years
• BMI between 20-25 kg/m^2

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Eplerenone

Experimental group

Description:

Eplerenone 50 mg daily for 14 days

Treatment:

Drug: Eplerenone