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The Effect of Acute Mild Dehydration on Blood Pressure Control

Primary Purpose

Mild Dehydration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal hydration
Dehydration
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild Dehydration focused on measuring Dehydration

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (Young):

• age: 20-35 years old

Exclusion Criteria (Young):

  • 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

Inclusion Criteria (Older):

  • age: 60-75 years old
  • ECG within normal limits
  • screening blood panel within normal limits

Exclusion Criteria (Older):

  • 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

Sites / Locations

  • William B Farquhar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal hydration then dehydration

Dehydration than normal hydration

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
June 6, 2018
Last Updated
January 5, 2021
Sponsor
University of Delaware
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT03560869
Brief Title
The Effect of Acute Mild Dehydration on Blood Pressure Control
Official Title
Sympathetic Reactivity to Water Restriction in Young and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
June 13, 2019 (Actual)
Study Completion Date
June 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Dehydration
Keywords
Dehydration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Normal Hydration and Dehydration
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal hydration then dehydration
Arm Type
Experimental
Arm Description
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).
Arm Title
Dehydration than normal hydration
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Normal hydration
Intervention Description
see description in 'arms'
Intervention Type
Other
Intervention Name(s)
Dehydration
Intervention Description
see description in 'arms'
Primary Outcome Measure Information:
Title
Blood Pressure Variability
Description
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.
Time Frame
During experimental visits 1 and 2
Title
Blood Pressure Reactivity - Handgrip Exercise
Description
Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).
Time Frame
During experimental visits 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Young): • age: 20-35 years old Exclusion Criteria (Young): 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 Inclusion Criteria (Older): age: 60-75 years old ECG within normal limits screening blood panel within normal limits Exclusion Criteria (Older): 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
Facility Information:
Facility Name
William B Farquhar
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31617739
Citation
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.
Results Reference
result
PubMed Identifier
31070954
Citation
Watso 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 Reference
result
PubMed Identifier
30794437
Citation
Robinson 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.
Results Reference
result

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The Effect of Acute Mild Dehydration on Blood Pressure Control

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