The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise (S47)

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Normal Protein; Other: HIgh Protein

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 121 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1607017949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plans to share data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No