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

Not Applicable

Completed

• Conditions: Blood Pressure; Cardiovascular Risk Factor
• Interventions: Other: Normal Protein; Other: HIgh Protein

• Registration Number: NCT03073252
• Lead Sponsor: Purdue University

Brief Summary

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

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,

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Protein	Normal Protein	Consumption of high protein (HP) meal
High Protein	HIgh Protein	Consumption of high protein (HP) meal
Normal Protein	Normal Protein	Consumption of normal protein (NP) meal
Normal Protein	HIgh Protein	Consumption of normal protein (NP) meal

Primary Outcome Measures

Name	Time	Method
Blood Pressure Changes	6hr testing	Changes from Baseline to Post Systolic Blood Pressure during 30 minute exercise session

Secondary Outcome Measures

Name	Time	Method
Vasoactive Molecules	6 hrs	Vasoactive Molecules analysis using plasma

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States