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

NCT03073252 | Completed

• 1 other identifier: 1607017949
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Blood Pressure Changes

  Changes from Baseline to Post Systolic Blood Pressure during 30 minute exercise session

  6hr testing

Secondary Outcomes (1)

• Vasoactive Molecules

  6 hrs

Study Arms (2)

Normal Protein

EXPERIMENTAL

Consumption of normal protein (NP) meal

Other: Normal Protein; Other: HIgh Protein

High Protein

EXPERIMENTAL

Consumption of high protein (HP) meal

Other: Normal Protein; Other: HIgh Protein

Interventions

Normal Protein OTHER

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

High Protein; Normal Protein

HIgh Protein OTHER

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

High Protein; Normal Protein

Eligibility Criteria

• Age: 21 Years - 121 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care provider will randomize participants and keep the participant, investigator and outcomes assessor blinded to the randomization.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 8, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)