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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

Tracking Information
First Submitted Date  ICMJE June 6, 2018
First Posted Date  ICMJE June 18, 2018
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE August 8, 2017
Actual Primary Completion Date June 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • Blood Pressure Variability [ Time Frame: Day following each hydration protocol ]
    Average real variability of systolic blood pressure
  • Blood Pressure Reactivity - Handgrip exercise [ Time Frame: Day following each hydration protocol ]
    Change in Blood pressure during handgrip exercise (mmHg)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Acute Mild Dehydration on Blood Pressure Control
Official Title  ICMJE The Effect of Acute Mild Dehydration on Blood Pressure Control
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Mild Dehydration
Intervention  ICMJE Other: Hydration State
Hydration State
Study Arms  ICMJE
  • Active Comparator: Normal Hydration
    Participants will consume water to maintain proper hydration for three days prior to testing.
    Intervention: Other: 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.
    Intervention: Other: Hydration State
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
40
Actual Study Completion Date  ICMJE June 13, 2019
Actual Primary Completion Date June 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03560869
Other Study ID Numbers  ICMJE 1097747
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Delaware
Study Sponsor  ICMJE University of Delaware
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Delaware
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP