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

Blood Pressure Clinical Trial

— S47  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073252
• Other study ID #: 1607017949
• Status: Completed
• Phase: N/A
• First received: February 14, 2017
• Last updated: January 9, 2018
• Start date: January 1, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: January 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 121 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Risk Factor

Intervention

Other:
• Normal Protein
Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl
• HIgh Protein
Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Changes	Changes from Baseline to Post Systolic Blood Pressure during 30 minute exercise session	6hr testing
Secondary	Vasoactive Molecules	Vasoactive Molecules analysis using plasma	6 hrs