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The Effect of Acute Mild Dehydration on Blood Pressure Control

Sympathetic Reactivity to Water Restriction in Young and Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03560869
Enrollment
35
Registered
2018-06-18
Start date
2017-08-08
Completion date
2019-06-13
Last updated
2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Dehydration

Keywords

Dehydration

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.

Interventions

OTHERNormal hydration

see description in 'arms'

OTHERDehydration

see description in 'arms'

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Intervention model description

Normal Hydration and Dehydration

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure VariabilityDuring experimental visits 1 and 2Blood 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 ExerciseDuring experimental visits 1 and 2Change in systolic blood pressure during the second-minute handgrip exercise minus compared to pre-exercise baseline (i.e., at rest).

Countries

United States

Participant flow

Pre-assignment details

All participants completed both conditions.

Participants by arm

ArmCount
All Study Participants
All Study Participants
35
Total35

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyScreening failure44
Overall StudyWithdrawal by PI01
Overall StudyWithdrawal by Subject34

Baseline characteristics

CharacteristicAll Study Participants
Age, Continuous47 years
STANDARD_DEVIATION 22
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
28 Participants
Region of Enrollment
United States
35 Participants
Sex: Female, Male
Female
27 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 35
other
Total, other adverse events
0 / 350 / 35
serious
Total, serious adverse events
0 / 350 / 35

Outcome results

Primary

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).

Time frame: During experimental visits 1 and 2

Population: 4 adults were excluded from this analysis due to technical difficulties

ArmMeasureValue (MEAN)Dispersion
Normal HydrationBlood Pressure Reactivity - Handgrip Exercise20 mmHgStandard Deviation 11
DehydrationBlood Pressure Reactivity - Handgrip Exercise18 mmHgStandard Deviation 8
Primary

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.

Time frame: During experimental visits 1 and 2

ArmMeasureValue (MEAN)Dispersion
Normal HydrationBlood Pressure Variability2.6 mmHgStandard Deviation 1.1
DehydrationBlood Pressure Variability2.5 mmHgStandard Deviation 0.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026