Comparison of the Beverage Hydration Index of Different Solutions

April 5, 2025 updated by: Richard Bloomer, University of Memphis
The present study will assess the effects of two different hydration solutions compared to water on hydration measures. It will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance. Additionally, hydration status will be assessed with mood and digestive health questionnaires and blood pressure urine electrolyte concentrations, specific gravity, and osmolality determinations. The two oral rehydration solutions (Berry Propel Fitness Water and Essentia Hydroboost Raspberry Pomegranate) will be compared to the control (Smart Water). The purpose is to assess whether the changes in beverage composition improve the BHI above water alone for both treatments, with an hypothesized greater improvement in BHI observed with the Essentia Hydroboost Raspberry Pomegranate, due to the addition of carbohydrate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The present study will assess the effects of two different hydration solutions compared to water on hydration measures. It will follow the same approach as used by Maughan and colleagues (2016) to measure the fluid balance (the difference between the amount of water consumed and passed as urine) and beverage hydration index (the relative amount of urine passed after consumption of a drink compared to water) including time in positive fluid balance. Additionally, hydration status will be assessed with mood and digestive health questionnaires and blood pressure urine electrolyte concentrations, specific gravity, and osmolality determinations. The two oral rehydration solutions (Berry Propel Fitness Water and Essentia Hydroboost Raspberry Pomegranate) will be compared to the control (Smart Water). The purpose is to assess whether the changes in beverage composition improve the BHI above water alone for both treatments, with an hypothesized greater improvement in BHI observed with the Essentia Hydroboost Raspberry Pomegranate, due to the addition of carbohydrate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38152
        • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • body mass index (BMI) <35 kg/m2 (not morbidly obese)
  • Cannot have a sensitivity or be allergic to any components of the study product they will be excluded.
  • non-tobacco user
  • cannot be following a specialized dietary pattern that may alter findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.)
  • willing to replicate the same dietary intake/activity (exercise) level for each day before a lab visit excluding screening
  • Will consume a minimum of 2 liters (women) or 2.5 liters (men) of water per day, on each day prior to experimental lab visits (excluding screening)
  • Will arrive to lab for visits euhydrated (USG 1.005-1.020)
  • Will not consume alcohol-containing beverages within 24 hours of testing
  • Will not consume caffeine-containing beverages within 12 hours of testing
  • can fast (consume water/treatments only) for 15 hours (10 hours prior to lab visits not including screening)
  • avoid strenuous activity for 24 hours prior to study visits excluding screening
  • Will not have a history or presence of a clinically relevant (that required or requires treatment) cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder (reviewed by Nurse practitioner)
  • Will not have other conditions that is likely to alter fluid balance or be negatively affected by changing electrolyte levels/hydration status (as determined by Nurse practitioner)
  • Is not consuming any medication which may alter fluid retention/electrolyte levels such as sodium-glucose co-transporter 2 (SGLT2) inhibitor (for type 2 diabetes), laxatives, diuretics, Apremilast, chemotherapy, or lithium. (Medications will be reviewed by Nurse practitioner)
  • Will not consume nutritional supplements, performance enhancing drugs, and/or non-steroidal anti-inflammatory drugs within 7 days of study visits excluding screening.
  • cannot be enrolled in another clinical study within 30 days of the first study visit
  • without active infection or illness of any kind

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Propel, Essentia, Smart
Subjects will follow control diet for 24 hours prior to visit. At the study visit, baseline measures will be collected prior to treatment. Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
Dietary supplement: Berry Propel Fitness Water
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Essentia Hydroboost Raspberry Pomegranate
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Smart Water
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
Experimental: Propel, Smart, Essentia
Subjects will follow control diet for 24 hours prior to visit. At the study visit, baseline measures will be collected prior to treatment. Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
Dietary supplement: Berry Propel Fitness Water
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Essentia Hydroboost Raspberry Pomegranate
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Smart Water
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
Experimental: Essentia, Smart, Propel
Subjects will follow control diet for 24 hours prior to visit. At the study visit, baseline measures will be collected prior to treatment. Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
Dietary supplement: Berry Propel Fitness Water
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Essentia Hydroboost Raspberry Pomegranate
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Smart Water
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
Active Comparator: Essentia, Propel, Smart
Subjects will follow control diet for 24 hours prior to visit. At the study visit, baseline measures will be collected prior to treatment. Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
Dietary supplement: Berry Propel Fitness Water
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Essentia Hydroboost Raspberry Pomegranate
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Smart Water
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
Experimental: Smart, Essentia, Propel
Subjects will follow control diet for 24 hours prior to visit. At the study visit, baseline measures will be collected prior to treatment. Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
Dietary supplement: Berry Propel Fitness Water
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Essentia Hydroboost Raspberry Pomegranate
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Smart Water
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.
Experimental: Smart, Propel, Essentia
Subjects will follow control diet for 24 hours prior to visit. At the study visit, baseline measures will be collected prior to treatment. Subjects will consume the assigned treatment (one treatment per visit in order state in arm title) and additional experimental measurements will be collected.
Dietary supplement: Berry Propel Fitness Water
Subject will consume 1 Liter of commercially available Berry Propel Fitness Water at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Essentia Hydroboost Raspberry Pomegranate
Subject will consume 1 Liter of commercially available Essentia Hydroboost Raspberry Pomegranate at a rate of 250 milliliters per 7.5 minutes
Dietary supplement: Smart Water
Subject will consume 1 Liter of commercially available Smart Water at a rate of 250 milliliters per 7.5 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beverage Hydration Index
Time Frame: 0 minutes after beverage consumption
Beverage Hydration Index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment
0 minutes after beverage consumption
Beverage Hydration Index
Time Frame: 60 minutes after beverage consumption
Beverage Hydration Index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment
60 minutes after beverage consumption
Beverage Hydration Index
Time Frame: 120 minutes after beverage consumption
Beverage Hydration Index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment
120 minutes after beverage consumption
Beverage Hydration Index
Time Frame: 180 minutes after beverage consumption
Beverage Hydration Index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment
180 minutes after beverage consumption
Beverage Hydration Index
Time Frame: 240 minutes after beverage consumption
Beverage Hydration Index calculated as mass of urine collected following control (water) consumption divided by the mass of urine collected following treatment
240 minutes after beverage consumption

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urine Osmolality
Time Frame: 0 minutes before beverage consumption
Urine Osmolality will be measured in milliosmoles per kilogram of water.
0 minutes before beverage consumption
Urine Osmolality
Time Frame: 0 minutes after beverage consumption
Urine Osmolality will be measured in milliosmoles per kilogram of water.
0 minutes after beverage consumption
Urine Osmolality
Time Frame: 60 minutes after beverage consumption
Urine Osmolality will be measured in milliosmoles per kilogram of water.
60 minutes after beverage consumption
Urine Osmolality
Time Frame: 120 minutes after beverage consumption
Urine Osmolality will be measured in milliosmoles per kilogram of water.
120 minutes after beverage consumption
Urine Osmolality
Time Frame: 180 minutes after beverage consumption
Urine Osmolality will be measured in milliosmoles per kilogram of water.
180 minutes after beverage consumption
Urine Osmolality
Time Frame: 240 minutes after beverage consumption
Urine Osmolality will be measured in milliosmoles per kilogram of water.
240 minutes after beverage consumption
Urine Specific Gravity
Time Frame: 150 minutes before beverage consumption
Urine Specific Gravity will be measured via refractometry.
150 minutes before beverage consumption
Mood and Digestive Questionnaire
Time Frame: 0 minutes before beverage consumption
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
0 minutes before beverage consumption
Mood and Digestive Questionnaire
Time Frame: 0 minutes after beverage consumption
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
0 minutes after beverage consumption
Mood and Digestive Questionnaire
Time Frame: 60 minutes after beverage consumption
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
60 minutes after beverage consumption
Mood and Digestive Questionnaire
Time Frame: 120 minutes after beverage consumption
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
120 minutes after beverage consumption
Mood and Digestive Questionnaire
Time Frame: 180 minutes after beverage consumption
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
180 minutes after beverage consumption
Mood and Digestive Questionnaire
Time Frame: 240 minutes after beverage consumption
Subjects will be asked to self-assess their mood and digestive state via a visual analog scale questionnaire with scale 0 (None) to 10 (Extreme)
240 minutes after beverage consumption
Net Fluid Balance
Time Frame: 0 minutes after beverage consumption
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
0 minutes after beverage consumption
Net Fluid Balance
Time Frame: 60 minutes after beverage consumption
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
60 minutes after beverage consumption
Net Fluid Balance
Time Frame: 120 minutes after beverage consumption
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
120 minutes after beverage consumption
Net Fluid Balance
Time Frame: 180 minutes after beverage consumption
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
180 minutes after beverage consumption
Net Fluid Balance
Time Frame: 240 minutes after beverage consumption
Net fluid balance will be calculated subtracting the total urine collected from the total liquid consumed
240 minutes after beverage consumption
Urine Sodium
Time Frame: 0 minutes before beverage consumption
Urine Sodium will be measure in millimoles per liter.
0 minutes before beverage consumption
Urine Sodium
Time Frame: 0 minutes after beverage consumption
Urine Sodium will be measure in millimoles per liter.
0 minutes after beverage consumption
Urine Sodium
Time Frame: 60 minutes after beverage consumption
Urine Sodium will be measure in millimoles per liter.
60 minutes after beverage consumption
Urine Sodium
Time Frame: 120 minutes after beverage consumption
Urine Sodium will be measure in millimoles per liter.
120 minutes after beverage consumption
Urine Sodium
Time Frame: 180 minutes after beverage consumption
Urine Sodium will be measure in millimoles per liter.
180 minutes after beverage consumption
Urine Sodium
Time Frame: 240 minutes after beverage consumption
Urine Sodium will be measure in millimoles per liter.
240 minutes after beverage consumption
Urine Potassium
Time Frame: 0 minutes before beverage consumption
Urine Potassium will be measure in millimoles per liter.
0 minutes before beverage consumption
Urine Potassium
Time Frame: 0 minutes after beverage consumption
Urine Potassium will be measure in millimoles per liter.
0 minutes after beverage consumption
Urine Potassium
Time Frame: 60 minutes after beverage consumption
Urine Potassium will be measure in millimoles per liter.
60 minutes after beverage consumption
Urine Potassium
Time Frame: 120 minutes after beverage consumption
Urine Potassium will be measure in millimoles per liter.
120 minutes after beverage consumption
Urine Potassium
Time Frame: 180 minutes after beverage consumption
Urine Potassium will be measure in millimoles per liter.
180 minutes after beverage consumption
Urine Potassium
Time Frame: 240 minutes after beverage consumption
Urine Potassium will be measure in millimoles per liter.
240 minutes after beverage consumption
Urine Specific Gravity
Time Frame: 0 minutes before beverage consumption
Urine Specific Gravity will be measured via refractometry.
0 minutes before beverage consumption
Urine Specific Gravity
Time Frame: 0 minutes after beverage consumption
Urine Specific Gravity will be measured via refractometry.
0 minutes after beverage consumption
Urine Specific Gravity
Time Frame: 60 minutes after beverage consumption
Urine Specific Gravity will be measured via refractometry.
60 minutes after beverage consumption
Urine Specific Gravity
Time Frame: 120 minutes after beverage consumption
Urine Specific Gravity will be measured via refractometry.
120 minutes after beverage consumption
Urine Specific Gravity
Time Frame: 180 minutes after beverage consumption
Urine Specific Gravity will be measured via refractometry.
180 minutes after beverage consumption
Urine Specific Gravity
Time Frame: 240 minutes after beverage consumption
Urine Specific Gravity will be measured via refractometry.
240 minutes after beverage consumption
Body Mass
Time Frame: 0 minutes before beverage consumption
Body Mass in kilograms will be measured using a digital scale.
0 minutes before beverage consumption
Body Mass
Time Frame: 240 minutes after beverage consumption
Body Mass in kilograms will be measured using a digital scale.
240 minutes after beverage consumption
Diastolic Blood Pressure
Time Frame: 0 minutes before beverage consumption
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
0 minutes before beverage consumption
Diastolic Blood Pressure
Time Frame: 0 minutes after beverage consumption
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
0 minutes after beverage consumption
Diastolic Blood Pressure
Time Frame: 60 minutes after beverage consumption
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
60 minutes after beverage consumption
Diastolic Blood Pressure
Time Frame: 120 minutes after beverage consumption
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
120 minutes after beverage consumption
Diastolic Blood Pressure
Time Frame: 180 minutes after beverage consumption
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
180 minutes after beverage consumption
Diastolic Blood Pressure
Time Frame: 240 minutes after beverage consumption
Diastolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
240 minutes after beverage consumption
Systolic Blood Pressure
Time Frame: 0 minutes before beverage consumption
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
0 minutes before beverage consumption
Systolic Blood Pressure
Time Frame: 0 minutes after beverage consumption
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
0 minutes after beverage consumption
Systolic Blood Pressure
Time Frame: 60 minutes after beverage consumption
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
60 minutes after beverage consumption
Systolic Blood Pressure
Time Frame: 120 minutes after beverage consumption
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
120 minutes after beverage consumption
Systolic Blood Pressure
Time Frame: 180 minutes after beverage consumption
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
180 minutes after beverage consumption
Systolic Blood Pressure
Time Frame: 240 minutes after beverage consumption
Systolic Blood Pressure will be measured in millimeters mercury using an automated cuff.
240 minutes after beverage consumption
Heart Rate
Time Frame: 0 minutes before beverage consumption
Heart rate will be measured in beats per minute using an automated cuff.
0 minutes before beverage consumption
Heart Rate
Time Frame: 0 minutes after beverage consumption
Heart rate will be measured in beats per minute using an automated cuff.
0 minutes after beverage consumption
Heart Rate
Time Frame: 60 minutes after beverage consumption
Heart rate will be measured in beats per minute using an automated cuff.
60 minutes after beverage consumption
Heart Rate
Time Frame: 120 minutes after beverage consumption
Heart rate will be measured in beats per minute using an automated cuff.
120 minutes after beverage consumption
Heart Rate
Time Frame: 180 minutes after beverage consumption
Heart rate will be measured in beats per minute using an automated cuff.
180 minutes after beverage consumption
Heart Rate
Time Frame: 240 minutes after beverage consumption
Heart rate will be measured in beats per minute using an automated cuff.
240 minutes after beverage consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Memphis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard J Bloomer, PhD, University of Memphis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-FY2024-372

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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