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Completed

NCT Number: NCT03073252

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

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.

Completed

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Key information

Age range

21 year–121 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Protein

Other

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

HIgh Protein

Other

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

Primary outcomes

  1. Blood Pressure Changes

    Time frame: 6hr testing

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

Secondary outcomes

  1. Vasoactive Molecules

    Time frame: 6 hrs

    Vasoactive Molecules analysis using plasma

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Acronym: S47

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2017
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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