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

NCT ID: NCT03073252

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-06-30

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,

Conditions

Blood Pressure; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Normal Protein

Consumption of normal protein (NP) meal

Group Type: EXPERIMENTAL

Normal Protein

Intervention Type: OTHER

Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl

HIgh Protein

Intervention Type: OTHER

Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl

High Protein

Consumption of high protein (HP) meal

Group Type: EXPERIMENTAL

Normal Protein

Intervention Type: OTHER

Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl

HIgh Protein

Intervention Type: OTHER

Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl

Interventions

Normal Protein

Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl

Intervention Type: OTHER

HIgh Protein

Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 121 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

1607017949

Identifier Type: -

Identifier Source: org_study_id