Mild DehydrationNCT03560869
The Effect of Acute Mild Dehydration on Blood Pressure Control
A study testing Normal hydration and Dehydration in people with Mild Dehydration, run by University of Delaware at 1 site in United States.
Trial summary
The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Dehydration
- What is being tested?
- Normal hydration and Dehydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 13 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: 20-35 years old
- age: 60-75 years old
- ECG within normal limits
- screening blood panel within normal limits
Who cannot join
- high blood pressure (>140/90 mmHg)
- history of cardiovascular disease
- history of cancer
- history of diabetes
- history of kidney disease
- obesity (BMI > 30 kg/m2)
Show all 20Show fewer
- smoking or tobacco use
- current pregnancy
- nursing mothers
- communication barriers
- high blood pressure (>140/90 mmHg)
- history of cardiovascular disease
- history of cancer
- history of diabetes
- history of kidney disease
- obesity (BMI > 30 kg/m2)
- smoking or tobacco use
- current pregnancy
- nursing mothers
- communication barriers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sympathetic Reactivity to Water Restriction in Young and Older Adults
The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition.
Read the detailed description
The purpose of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. Additionally, we will determine whether or not the sympathetic nervous system has a role in mediating blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition. This will allow for a within participant comparison. Additionally, we will later determine if age alters blood pressure control at rest or during static exercise.
- Conditions
- Mild Dehydration
- Being tested
- Normal hydration, Dehydration
- Keywords
- Dehydration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal hydrationOther
see description in 'arms'
DehydrationOther
see description in 'arms'
| Study group | Role | What they receive |
|---|---|---|
| Normal hydration then dehydration | Experimental | Participants will consume water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 2). Receives: Other: Normal hydration; Other: Dehydration |
| Dehydration than normal hydration | Experimental | Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants will consume water to maintain proper hydration for three days prior to testing (visit 2). Receives: Other: Normal hydration; Other: Dehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Variability
Blood pressure variability (BPV) was calculated using standard deviation and using the average real variability index of blood pressure values. The average real variability index calculates the average of absolute differences between consecutive BP measurements and is thought to provide further prognostic value compared with traditional measures of BPV.
Measured: During experimental visits 1 and 2
Blood Pressure Reactivity - Handgrip Exercise
Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).
Measured: During experimental visits 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start8 Aug 2017
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild DehydrationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Normal Hydration and Dehydration
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560869
- Sponsor's protocol ID
- 1097747
- Other IDs
- R01HL128388, 5P20GM113125
- Status last verified
- Jan 2021
- First submitted
- 6 Jun 2018
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Watso JC, Robinson AT, Babcock MC, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Short-term water deprivation does not increase blood pressure variability or impair neurovascular function in healthy young adults. Am J Physiol Regul Integr Comp Physiol. 2020 Jan 1;318(1):R112-R121. doi: 10.1152/ajpregu.00149.2019. Epub 2019 Oct 16.
PubMed 31617739Watso JC, Babcock MC, Robinson AT, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Water deprivation does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans. J Appl Physiol (1985). 2019 Jul 1;127(1):235-245. doi: 10.1152/japplphysiol.00005.2019. Epub 2019 May 9.
PubMed 31070954Robinson AT, Babcock MC, Watso JC, Brian MS, Migdal KU, Wenner MM, Farquhar WB. Relation between resting sympathetic outflow and vasoconstrictor responses to sympathetic nerve bursts: sex differences in healthy young adults. Am J Physiol Regul Integr Comp Physiol. 2019 May 1;316(5):R463-R471. doi: 10.1152/ajpregu.00305.2018. Epub 2019 Feb 22.
PubMed 30794437
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Reactivity to Water Restriction in Young and Older Adults
- ClinicalTrials.gov ID
- NCT03560869
- Acronym / sponsor ID
- 1097747
- Conditions
- Mild Dehydration
- Keywords
- Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institute of General Medical Sciences (NIGMS)
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition.
Detailed description
The purpose of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. Additionally, we will determine whether or not the sympathetic nervous system has a role in mediating blood pressure control at rest and during static exercise. This protocol will test healthy young and older adults in a normally hydrated and dehydrated condition. This will allow for a within participant comparison. Additionally, we will later determine if age alters blood pressure control at rest or during static exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Normal Hydration and Dehydration
| Arm | Type | Receives |
|---|---|---|
| Normal hydration then dehydration | Experimental | Other: Normal hydration, Other: DehydrationParticipants will consume water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 2). |
| Dehydration than normal hydration | Experimental | Other: Normal hydration, Other: DehydrationParticipants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants will consume water to maintain proper hydration for three days prior to testing (visit 2). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: 20-35 years old
- age: 60-75 years old
- ECG within normal limits
- screening blood panel within normal limits
Key exclusion criteria (20 listed)
- high blood pressure (>140/90 mmHg)
- history of cardiovascular disease
- history of cancer
- history of diabetes
- history of kidney disease
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 hydrationsee description in 'arms' | Other | Dehydration than normal hydration, Normal hydration then dehydration |
| Dehydrationsee description in 'arms' | Other | Dehydration than normal hydration, Normal hydration then dehydration |
Primary outcome
Blood Pressure Variability
Time frame: During experimental visits 1 and 2
Blood pressure variability (BPV) was calculated using standard deviation and using the average real variability index of blood pressure values. The average real variability index calculates the average of absolute differences between consecutive BP measurements and is thought to provide further prognostic value compared with traditional measures of BPV.
Blood Pressure Reactivity - Handgrip Exercise
Time frame: During experimental visits 1 and 2
Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31617739Watso JC, Robinson AT, Babcock MC, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Short-term water deprivation does not increase blood pressure variability or impair neurovascular function in healthy young adults. Am J Physiol Regul Integr Comp Physiol. 2020 Jan 1;318(1):R112-R121. doi: 10.1152/ajpregu.00149.2019. Epub 2019 Oct 16.
- Results publication: PubMed 31070954Watso JC, Babcock MC, Robinson AT, Migdal KU, Wenner MM, Stocker SD, Farquhar WB. Water deprivation does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans. J Appl Physiol (1985). 2019 Jul 1;127(1):235-245. doi: 10.1152/japplphysiol.00005.2019. Epub 2019 May 9.
- Results publication: PubMed 30794437Robinson AT, Babcock MC, Watso JC, Brian MS, Migdal KU, Wenner MM, Farquhar WB. Relation between resting sympathetic outflow and vasoconstrictor responses to sympathetic nerve bursts: sex differences in healthy young adults. Am J Physiol Regul Integr Comp Physiol. 2019 May 1;316(5):R463-R471. doi: 10.1152/ajpregu.00305.2018. Epub 2019 Feb 22.
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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 hydration and Dehydration in people with Mild Dehydration, run by University of Delaware 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 4 inclusion and 20 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 27 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Variability (time frame: During experimental visits 1 and 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560869, which also lists 3 linked publications.
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 27 Jan 2021.