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The Effect of Acute Mild Dehydration on Blood Pressure Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03560869
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Delaware

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.

Condition or disease Intervention/treatment Phase
Mild Dehydration Other: Hydration State Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Normal Hydration and Dehydration Estimated number of subjects to complete both protocols = 20 young adults & 20 older adults
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Acute Mild Dehydration on Blood Pressure Control
Actual Study Start Date : August 8, 2017
Actual Primary Completion Date : June 13, 2019
Actual Study Completion Date : June 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

Arm Intervention/treatment
Active Comparator: Normal Hydration
Participants will consume water to maintain proper hydration for three days prior to testing.
Other: Hydration State
Hydration State

Experimental: Dehydration
Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing.
Other: Hydration State
Hydration State




Primary Outcome Measures :
  1. Blood Pressure Variability [ Time Frame: Day following each hydration protocol ]
    Average real variability of systolic blood pressure

  2. Blood Pressure Reactivity - Handgrip exercise [ Time Frame: Day following each hydration protocol ]
    Change in Blood pressure during handgrip exercise (mmHg)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560869


Locations
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United States, Delaware
William B Farquhar
Newark, Delaware, United States, 19713
Sponsors and Collaborators
University of Delaware

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Responsible Party: University of Delaware
ClinicalTrials.gov Identifier: NCT03560869    
Other Study ID Numbers: 1097747
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Delaware:
Dehydration
Additional relevant MeSH terms:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes