Effect of Eplerenone on Postprandial Inflammatory Response in Healthy Adults

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Systemic Proinflammatory State

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Eplerenone

Eplerenone 50 mg daily for 14 days

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

50 mg daily for 14 days

Interventions

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Eplerenone

50 mg daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes