Blood PressureS47NCT03073252
The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise
A study testing Normal Protein and HIgh Protein in people with Blood Pressure and Cardiovascular Risk Factor, run by Purdue University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 121 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Cardiovascular Risk Factor
- What is being tested?
- Normal Protein and HIgh Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 121 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Normal Protein, HIgh Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal ProteinOther
Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl
HIgh ProteinOther
Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl
| Study group | Role | What they receive |
|---|---|---|
| Normal Protein | Experimental | Consumption of normal protein (NP) meal Receives: Other: Normal Protein; Other: HIgh Protein |
| High Protein | Experimental | Consumption of high protein (HP) meal Receives: Other: Normal Protein; Other: HIgh Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Changes
Changes from Baseline to Post Systolic Blood Pressure during 30 minute exercise session
Measured: 6hr testing
Secondary outcomes (1)
Vasoactive Molecules
Vasoactive Molecules analysis using plasma
Measured: 6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Jan 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073252
- Sponsor's protocol ID
- 1607017949
- Acronym
- S47
- Status last verified
- Jan 2018
- First submitted
- 14 Feb 2017
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plans to share data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Egg-Based High Protein Meal on Hypertensive Response to Exercise
- ClinicalTrials.gov ID
- NCT03073252
- Acronym / sponsor ID
- S47 / 1607017949
- Conditions
- Blood Pressure, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- subject will consume either the 13g or 30g protein breakfast in a randomized cross-over manner
| Arm | Type | Receives |
|---|---|---|
| Normal Protein | Experimental | Other: Normal Protein, Other: HIgh ProteinConsumption of normal protein (NP) meal |
| High Protein | Experimental | Other: Normal Protein, Other: HIgh ProteinConsumption of high protein (HP) meal |
Who may qualify
- Ages
- 21 to 121 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (17 listed)
- Hypertensive
- Body weight ≥ 300 lb
- BMI <20 or >35 kg/m2
- Pregnant or planning pregnancy
- Unwilling to consume study foods and beverages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal ProteinConsumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl | Other | High Protein, Normal Protein |
| HIgh ProteinConsumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl | Other | High Protein, Normal Protein |
Primary outcome
Blood Pressure Changes
Time frame: 6hr testing
Changes from Baseline to Post Systolic Blood Pressure during 30 minute exercise session
1 secondary outcome
Vasoactive Molecules
Time frame: 6 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Individual participant dataSharing planned: No. no plans to share data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Protein and HIgh Protein in people with Blood Pressure and Cardiovascular Risk Factor, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Changes (time frame: 6hr testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.