NCT05916183

Brief Summary

The investigators want to understand the impact of the body losing and gaining water on brain function. Participants will restrict fluids consumed and exercise to lose 5% of body mass. Participants will then be provided fluid equal to the volume lost to consume over 2 hours (recovery). A series of brain function tests will be performed at baseline, following weight loss, and following recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

July 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

June 5, 2023

Last Update Submit

September 11, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Multitasking test

    Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome

    Upon completion of 5% body mass loss protocol, approximately 2 hours into the trial

  • Multitasking test

    Accuracy score of a multitasking test (0-100%) with greater scores indicating a better outcome

    2 hours following the dehydration cognitive function test, approximately 4.5 hours into the trial

Study Arms (1)

Dehydration and Rehydration Arm

EXPERIMENTAL

Participants will complete exercise until 5% body mass loss, followed by ad libitum rehydration throughout 2 hours of recovery.

Behavioral: Fluid loss and consumption

Interventions

Upon 5% body mass loss, rehydration of fluid lost to sweating throughout a 2 hour recovery period

Dehydration and Rehydration Arm

Eligibility Criteria

Age18 Years - 26 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Recreationally active
  • years old

You may not qualify if:

  • History of cardiovascular, metabolic, respiratory, neural, or renal disease
  • Hypertensive (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg) or tachycardic (resting heart rate ≥ 100 bpm) during the screening visit
  • Taking medication or supplements with a known side effect of affecting physiological responses to exercise (e.g., aspirin, acetaminophen, beta blockers, statins, stimulants, depressants, SSRIs)
  • Tobacco or nicotine use in the past six months
  • Current or past musculoskeletal injury impacting physical activity
  • Study physician discretion based on any other medical condition or medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Dehydration

Interventions

Economics

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Officials

  • Riana R Pryor, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 23, 2023

Study Start

July 5, 2023

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Coded data or the methodology will be shared with researchers upon reasonable written request.

Shared Documents
STUDY PROTOCOL
Time Frame
Data can be shared for as long as the data is retained, at least 7 years.
Access Criteria
Data will be shared upon reasonable written request.

Locations