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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL128388 | U.S. NIH Grant/Contract | View source | |
| 5P20GM113125 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal hydration | Other | see description in 'arms' |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | During experimental visits 1 and 2 |
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Inclusion Criteria (Young):
• age: 20-35 years old
Exclusion Criteria (Young):
Inclusion Criteria (Older):
Exclusion Criteria (Older):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William B Farquhar | Newark | Delaware | 19713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31617739 | Result | 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. | |
| 31070954 | Result | 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. |
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All participants completed both conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Hydration Than Dehydration | 14 participants consumed water to maintain proper hydration for three days prior to testing (visit 1). Seven to 60 days later, participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 2). |
| FG001 | Dehydration Than Normal Hydration | 21 participants reduced water intake over three days and abstained from any water for the final 16 hours prior to testing (visit 1). Seven to 60 days later, participants consumed water to maintain proper hydration for three days prior to testing (visit 2). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mmHg | During experimental visits 1 and 2 |
|
Adverse event data were monitored throughout the study (during experimental protocol #1 (3 days), study visit #1 (1 day), washout (up to 60 days), experimental protocol #2 (3 days), study visit #2 (1 day), and the week (7 days) following this final study visit - i.e., up to 75 days).
There were no adverse events, thus, there are no adverse event outcomes reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Hydration | Participants will consume water to maintain proper hydration for three days prior to testing. Hydration State: Hydration State |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William B. Farquhar | University of Delaware | 302-831-6178 | wbf@udel.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2018 | Mar 24, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 6, 2019 | Nov 9, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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Normal Hydration and Dehydration
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| Dehydration | Other | see description in 'arms' |
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| 30794437 | Result | 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. |
| Withdrawal by PI |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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). | 4 adults were excluded from this analysis due to technical difficulties | Posted | Mean | Standard Deviation | mmHg | During experimental visits 1 and 2 |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Dehydration | Participants will reduce water intake over three days and abstain from any water for the final 16 hours prior to testing. Hydration State: Hydration State | 0 | 35 | 0 | 35 | 0 | 35 |
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| D013568 | Pathological Conditions, Signs and Symptoms |