The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise

Study Overview
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Brief Summary
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The primary purpose of this study is to explore the effect of high versus normal egg-based protein meals on acute exercise-induced elevated blood pressure.

Detailed Description
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This study is designed to assess BP changes during and post- exercise after consumption of a test breakfast. The design consists of three visits. The first visit will assess each participants aerobic exercise capacity (VO2 max). Visit 2 and 3 will be clinical testing days where the subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner and perform the exercise intervention. BP changes will be monitored before and after breakfast consumption, during the exercise intervention,

Official Title
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The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise

Conditions
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Blood Pressure, Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Normal Protein
* Other: HIgh Protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-hypertensive (systolic, 120-139 mm Hg; diastolic, 80-89 mm Hg Age ≥ 21 Body weight <300 lb (136 kg) BMI between 20 and 34.9 kg/m2 Fasting plasma glucose <6.1 mmol/L, total cholesterol <6.7 mmol/L LDL cholesterol <4.1 mmol/L TG <4.5 mmol/L No pre-existing or history of cardiovascular, renal or liver disease Not currently or previously (past 6 mo) consuming a weight-loss diet or other special/non-balanced diets No weight loss/gain (±4.5 kg) within the past 6 mo No physical impairments preventing properly exercise execution No caffeine intake the day of testing Exclusion Criteria: Hypertensive Body weight ≥ 300 lb BMI <20 or >35 kg/m2 Pregnant or planning pregnancy Unwilling to consume study foods and beverages Fasting plasma glucose ≥6.1 mmol/L Total cholesterol ≥6.7 mmol/L LDL cholesterol ≥4.1 mmol/L TG ≥4.5 mmol/L acute illness smoking diabetic pre-existing or history of cardiovascular, renal or liver disease currently or previously (past 6 mo) consuming a weight-loss diet or other special/non-balanced diets weight loss/gain (±4.5 kg) within the past 6 months physical impairments preventing properly exercise execution caffeine the day of testing

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 121 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Protein<br>Consumption of normal protein (NP) meal | Other: Normal Protein<br>* Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl<br>Other: HIgh Protein<br>* Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl<br>|
| Experimental: High Protein<br>Consumption of high protein (HP) meal | Other: Normal Protein<br>* Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl<br>Other: HIgh Protein<br>* Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Changes | Changes from Baseline to Post Systolic Blood Pressure during 30 minute exercise session | 6hr testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasoactive Molecules | Vasoactive Molecules analysis using plasma | 6 hrs |