Effects of Pre-Run Nutritional Supplements During a Fixed-Pace 5 km Treadmill Run

September 26, 2026 updated by: Hossein Rafiei, St. Louis University

Fueling the Kilometers: Effects of Pre-Run Nutritional Supplements on Physiological Responses During a Fixed-Pace 5 km Treadmill Run

This study will examine how three commonly used pre-run nutritional supplements-caffeine, L-citrulline, and an exogenous ketone supplement-affect physiological and perceptual responses during a fixed-pace 5 km treadmill run in healthy, physically active runners.

Participants will complete one screening and baseline visit followed by four experimental visits in a randomized order. At each experimental visit, participants will receive caffeine, L-citrulline, an exogenous ketone supplement, or placebo before completing a fixed-pace 5 km treadmill run. Each participant will receive all four conditions and will therefore serve as their own control.

The study will evaluate measures including running economy, heart-rate responses, oxygen consumption, respiratory measures, blood lactate and ketone concentrations, perceived exertion, gastrointestinal symptoms, fatigue, energy, and focus. A randomly selected subgroup will also wear a continuous glucose monitor to explore glucose responses during the experimental visits. The study will also assess the feasibility and tolerability of completing repeated treadmill trials under the four supplement conditions.

Study Overview

Status

Status

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

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

This is a randomized, single-blind, placebo-controlled crossover study designed to compare acute physiological and perceptual responses to three pre-run nutritional supplements and placebo during a controlled fixed-pace 5 km treadmill run. Healthy, physically active runners will complete one screening/baseline visit and four experimental visits. Each participant will complete all four experimental conditions in randomized order and will serve as their own control. A minimum washout/recovery period of four days will separate experimental visits.

At each experimental visit, participants will receive one of four pre-run conditions: caffeine at 4 mg/kg body weight, L-citrulline at 7 g, an exogenous ketone supplement providing 11.5 g beta-hydroxybutyrate (BHB), or placebo. Study products will be provided in a standardized beverage vehicle, followed by a 45-minute waiting period before the treadmill run.

The primary physiological outcomes of interest are running economy and heart-rate drift during the fixed-pace 5 km treadmill run. Additional outcomes include oxygen consumption, carbon dioxide production, ventilation, respiratory exchange ratio, heart-rate recovery, capillary blood lactate and ketone concentrations, rating of perceived exertion, gastrointestinal symptoms, subjective fatigue, energy, focus, and participant-reported perceptions of the assigned supplement condition.

A prespecified randomly selected subgroup of up to 12 enrolled participants will use a Dexcom Stelo continuous glucose monitor during the experimental phase. CGM-derived glucose responses will be analyzed as exploratory outcomes within this subgroup only.

The study will also evaluate feasibility and tolerability, including visit completion, adverse events, supplement-related symptoms, gastrointestinal symptoms, and completeness of study measurements. The results are intended to characterize within-participant differences among the four conditions and provide preliminary data for future confirmatory studies.

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 (Estimated)

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.
20

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

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-35 years
  • Healthy adult
  • Able to provide written informed consent
  • Regularly engaged in running-based aerobic training at least 3 times per week for at least 30 minutes per session during the past 3 months
  • Able to complete a 5 km run in under 30 minutes
  • Able and willing to comply with treadmill testing, fingerstick testing, dietary standardization, supplement restrictions, and pre-visit instructions
  • Participants randomly selected for the continuous glucose monitoring subgroup must also be willing to undergo Dexcom Stelo continuous glucose monitor placement and wear

Exclusion Criteria:

  • Known cardiovascular, metabolic, pulmonary, or neurological disease that may increase the risk associated with exercise testing or materially influence study outcomes
  • Uncontrolled hypertension or another cardiovascular condition that, in the investigator's judgment, makes vigorous treadmill exercise unsafe
  • Diagnosed type 1 or type 2 diabetes mellitus or another known metabolic disease that may materially influence study outcomes
  • Pregnant, breastfeeding, or planning pregnancy during the study period
  • Current use of nitrate medications or phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil, tadalafil, or vardenafil
  • Known sensitivity or allergy to caffeine, L-citrulline, exogenous ketone/BHB salt products, or any study beverage ingredient
  • Current use of stimulant medications or other medications that may significantly influence cardiovascular, blood pressure, or metabolic responses to exercise, as determined by the investigator
  • Musculoskeletal injury or condition that limits safe treadmill running
  • Smoking or regular use of nicotine products
  • Recent illness, surgery, or hospitalization that, in the opinion of the investigators, may interfere with safe participation or study outcomes
  • Unable or unwilling to comply with study procedures or pre-visit standardization requirements
  • Running fewer than 3 times per week or otherwise not meeting the running-training inclusion criterion

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: Sequence 1: Caffeine-L-Citrulline-Placebo-Ketone

Participants assigned to this randomized crossover sequence will receive caffeine, followed by L-citrulline, placebo, and exogenous ketone across four experimental visits. Each intervention will be administered 45 minutes before a fixed-pace 5 km treadmill run. Experimental visits will be separated by a minimum washout/recovery period of four days.
Dietary supplement: Caffeine

Caffeine will be administered at exactly 4 mg/kg body weight. The individualized dose will be calculated using body weight measured at the baseline visit. The commercially manufactured capsule contents will be weighed by trained study staff using a calibrated analytical balance to obtain the protocol-specified dose. Caffeine will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: L-Citrulline

L-citrulline will be administered at exactly 7.0 g. The commercially manufactured pure L-citrulline powder will be weighed using a calibrated analytical balance, dispensed in the standardized study beverage, and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: Exogenous Ketone (Beta-Hydroxybutyrate)

The exogenous ketone condition will consist of one 15 g serving of Nutricost Ketone BHB Salt 4-in-1 Powder, providing 11.5 g beta-hydroxybutyrate (BHB) as calcium, magnesium, sodium, and potassium BHB salts. The supplement will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Other: placebo beverage

The placebo will be a study-prepared beverage containing water, food-grade lime flavoring, and stevia, with no active study supplement. It will use the same standardized final volume as the active conditions and will be consumed 45 minutes before the fixed-pace 5 km treadmill run.
Experimental: Sequence 2: L-Citrulline-Ketone-Caffeine-Placebo

Participants assigned to this randomized crossover sequence will receive L-citrulline, followed by exogenous ketone, caffeine, and placebo across four experimental visits. Each intervention will be administered 45 minutes before a fixed-pace 5 km treadmill run. Experimental visits will be separated by a minimum washout/recovery period of four days.
Dietary supplement: Caffeine

Caffeine will be administered at exactly 4 mg/kg body weight. The individualized dose will be calculated using body weight measured at the baseline visit. The commercially manufactured capsule contents will be weighed by trained study staff using a calibrated analytical balance to obtain the protocol-specified dose. Caffeine will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: L-Citrulline

L-citrulline will be administered at exactly 7.0 g. The commercially manufactured pure L-citrulline powder will be weighed using a calibrated analytical balance, dispensed in the standardized study beverage, and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: Exogenous Ketone (Beta-Hydroxybutyrate)

The exogenous ketone condition will consist of one 15 g serving of Nutricost Ketone BHB Salt 4-in-1 Powder, providing 11.5 g beta-hydroxybutyrate (BHB) as calcium, magnesium, sodium, and potassium BHB salts. The supplement will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Other: placebo beverage

The placebo will be a study-prepared beverage containing water, food-grade lime flavoring, and stevia, with no active study supplement. It will use the same standardized final volume as the active conditions and will be consumed 45 minutes before the fixed-pace 5 km treadmill run.
Experimental: Sequence 3: Ketone-Placebo-L-Citrulline-Caffeine

Participants assigned to this randomized crossover sequence will receive exogenous ketone, followed by placebo, L-citrulline, and caffeine across four experimental visits. Each intervention will be administered 45 minutes before a fixed-pace 5 km treadmill run. Experimental visits will be separated by a minimum washout/recovery period of four days.
Dietary supplement: Caffeine

Caffeine will be administered at exactly 4 mg/kg body weight. The individualized dose will be calculated using body weight measured at the baseline visit. The commercially manufactured capsule contents will be weighed by trained study staff using a calibrated analytical balance to obtain the protocol-specified dose. Caffeine will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: L-Citrulline

L-citrulline will be administered at exactly 7.0 g. The commercially manufactured pure L-citrulline powder will be weighed using a calibrated analytical balance, dispensed in the standardized study beverage, and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: Exogenous Ketone (Beta-Hydroxybutyrate)

The exogenous ketone condition will consist of one 15 g serving of Nutricost Ketone BHB Salt 4-in-1 Powder, providing 11.5 g beta-hydroxybutyrate (BHB) as calcium, magnesium, sodium, and potassium BHB salts. The supplement will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Other: placebo beverage

The placebo will be a study-prepared beverage containing water, food-grade lime flavoring, and stevia, with no active study supplement. It will use the same standardized final volume as the active conditions and will be consumed 45 minutes before the fixed-pace 5 km treadmill run.
Experimental: Sequence 4: Placebo-Caffeine-Ketone-L-Citrulline

Participants assigned to this randomized crossover sequence will receive placebo, followed by caffeine, exogenous ketone, and L-citrulline across four experimental visits. Each intervention will be administered 45 minutes before a fixed-pace 5 km treadmill run. Experimental visits will be separated by a minimum washout/recovery period of four days.
Dietary supplement: Caffeine

Caffeine will be administered at exactly 4 mg/kg body weight. The individualized dose will be calculated using body weight measured at the baseline visit. The commercially manufactured capsule contents will be weighed by trained study staff using a calibrated analytical balance to obtain the protocol-specified dose. Caffeine will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: L-Citrulline

L-citrulline will be administered at exactly 7.0 g. The commercially manufactured pure L-citrulline powder will be weighed using a calibrated analytical balance, dispensed in the standardized study beverage, and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Dietary supplement: Exogenous Ketone (Beta-Hydroxybutyrate)

The exogenous ketone condition will consist of one 15 g serving of Nutricost Ketone BHB Salt 4-in-1 Powder, providing 11.5 g beta-hydroxybutyrate (BHB) as calcium, magnesium, sodium, and potassium BHB salts. The supplement will be dispensed in the standardized study beverage and consumed 45 minutes before the fixed-pace 5 km treadmill run.

Other: placebo beverage

The placebo will be a study-prepared beverage containing water, food-grade lime flavoring, and stevia, with no active study supplement. It will use the same standardized final volume as the active conditions and will be consumed 45 minutes before the fixed-pace 5 km treadmill run.

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
Running Economy (VO₂) During the Fixed-Pace 5 km Treadmill Run
Time Frame: During the fixed-pace 5 km treadmill run at each of the four experimental visits, approximately 45 minutes after supplement/placebo ingestion.

Running economy will be assessed using oxygen consumption (VO₂) measured by indirect calorimetry during standardized portions of the fixed-pace 5 km treadmill run. Within-participant running-economy responses will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
During the fixed-pace 5 km treadmill run at each of the four experimental visits, approximately 45 minutes after supplement/placebo ingestion.
Heart-Rate Drift During the Fixed-Pace 5 km Treadmill Run
Time Frame: Throughout the fixed-pace 5 km treadmill run at each of the four experimental visits, approximately 45 minutes after supplement/placebo ingestion.

Heart-rate drift will be assessed from continuous heart-rate monitoring as the change in heart rate over the course of the fixed-pace 5 km treadmill run. Within-participant heart-rate drift will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
Throughout the fixed-pace 5 km treadmill run at each of the four experimental visits, approximately 45 minutes after supplement/placebo ingestion.

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
Mean Oxygen Consumption (VO₂) During the Fixed-Pace 5 km Treadmill Run
Time Frame: During the fixed-pace 5 km treadmill run at each of the four experimental visits, beginning approximately 45 minutes after supplement/placebo ingestion.

Oxygen consumption (VO₂) will be measured continuously by indirect calorimetry and summarized as the mean body-mass-normalized VO₂ (mL/kg/min) during the fixed-pace 5 km treadmill run. Within-participant mean VO₂ will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
During the fixed-pace 5 km treadmill run at each of the four experimental visits, beginning approximately 45 minutes after supplement/placebo ingestion.
Mean Carbon Dioxide Production (VCO₂) During the Fixed-Pace 5 km Treadmill Run
Time Frame: During the fixed-pace 5 km treadmill run at each of the four experimental visits, beginning approximately 45 minutes after supplement/placebo ingestion.

Carbon dioxide production (VCO₂) will be measured continuously by indirect calorimetry and summarized as the mean VCO₂ (L/min) during the fixed-pace 5 km treadmill run. Within-participant mean VCO₂ will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
During the fixed-pace 5 km treadmill run at each of the four experimental visits, beginning approximately 45 minutes after supplement/placebo ingestion.
Ventilation
Time Frame: During the fixed-pace 5 km treadmill run at each of the four experimental visits.

Pulmonary ventilation will be measured using indirect calorimetry during the fixed-pace 5 km treadmill run and compared across supplement conditions.
During the fixed-pace 5 km treadmill run at each of the four experimental visits.
Respiratory Exchange Ratio
Time Frame: During the fixed-pace 5 km treadmill run at each of the four experimental visits.

Respiratory exchange ratio (RER), calculated from oxygen consumption and carbon dioxide production, will be evaluated during the fixed-pace 5 km treadmill run and compared across supplement conditions.
During the fixed-pace 5 km treadmill run at each of the four experimental visits.
1-Minute Heart-Rate Recovery After the Fixed-Pace 5 km Treadmill Run
Time Frame: From exercise cessation to 60 seconds after completion of the fixed-pace 5 km treadmill run at each of the four experimental visits.

Heart-rate recovery will be calculated as the decrease in heart rate from the end of the fixed-pace 5 km treadmill run to 60 seconds after exercise cessation, expressed in beats per minute. Within-participant 1-minute heart-rate recovery will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
From exercise cessation to 60 seconds after completion of the fixed-pace 5 km treadmill run at each of the four experimental visits.
Capillary Blood Lactate Concentration
Time Frame: Immediately before and immediately after the fixed-pace 5 km treadmill run at each experimental visit.

Capillary blood lactate concentration will be measured using finger-prick blood sampling and a point-of-care analyzer before and after exercise. Pre- to post-exercise responses will be compared across supplement conditions.
Immediately before and immediately after the fixed-pace 5 km treadmill run at each experimental visit.
Capillary Blood Ketone Concentration
Time Frame: Immediately before and immediately after the fixed-pace 5 km treadmill run at each experimental visit.

Capillary blood ketone concentration will be measured using finger-prick blood sampling and a point-of-care analyzer before and after exercise. Pre- to post-exercise responses will be compared across supplement conditions.
Immediately before and immediately after the fixed-pace 5 km treadmill run at each experimental visit.
Rating of Perceived Exertion
Time Frame: During and immediately following the fixed-pace 5 km treadmill run at each experimental visit.

Rating of perceived exertion will be assessed using the Borg 6-20 Rating of Perceived Exertion scale, where 6 represents no exertion and 20 represents maximal exertion; higher scores indicate greater perceived exertion.
During and immediately following the fixed-pace 5 km treadmill run at each experimental visit.
Gastrointestinal Symptoms Severity
Time Frame: During and immediately following the fixed-pace 5 km treadmill run at each experimental visit.

Gastrointestinal symptoms, including nausea, urge to vomit, bloating, belching, and abdominal cramping, will be assessed using visual analog scales anchored from no symptoms to the worst imaginable severity for each symptom. Higher values indicate greater symptom severity. Responses will be compared across the four supplement conditions.
During and immediately following the fixed-pace 5 km treadmill run at each experimental visit.
Subjective Fatigue
Time Frame: Immediately before supplement/placebo ingestion and immediately following the fixed-pace 5 km treadmill run at each experimental visit.

Participant-reported fatigue will be assessed using a single-item 0-10 numeric rating scale, where 0 indicates no fatigue and 10 indicates extreme fatigue. Scores and within-visit changes will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
Immediately before supplement/placebo ingestion and immediately following the fixed-pace 5 km treadmill run at each experimental visit.
Subjective Energy Level
Time Frame: Immediately before supplement/placebo ingestion and immediately following the fixed-pace 5 km treadmill run at each experimental visit.

Participant-reported energy will be assessed using a single-item 0-10 numeric rating scale, where 0 indicates no energy at all and 10 indicates extremely high energy. Scores and within-visit changes will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
Immediately before supplement/placebo ingestion and immediately following the fixed-pace 5 km treadmill run at each experimental visit.
Subjective Mental Focus
Time Frame: Immediately before supplement/placebo ingestion and immediately following the fixed-pace 5 km treadmill run at each experimental visit.

Participant-reported mental focus will be assessed using a single-item 0-10 numeric rating scale, where 0 indicates not at all focused and 10 indicates extremely focused. Scores and within-visit changes will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
Immediately before supplement/placebo ingestion and immediately following the fixed-pace 5 km treadmill run at each experimental visit.
Participant-Reported Guess of Assigned Supplement Condition
Time Frame: Immediately following completion of each experimental visit.

Following each experimental visit, participants will report which supplement condition they believe they received. Responses will be summarized and compared with the actual assigned condition to evaluate participant perception of treatment assignment.
Immediately following completion of each experimental visit.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interstitial Glucose Response During the Experimental-Visit Window in the CGM Subgroup
Time Frame: From pre-supplement baseline through completion of the immediate post-exercise assessments at each experimental visit.

Interstitial glucose will be measured continuously using continuous glucose monitoring in the prespecified randomly selected CGM subgroup. Only CGM data collected from the pre-supplement baseline through completion of the immediate post-exercise assessments at each experimental visit will be retained for analysis. Inter-visit CGM data will not be analyzed. Within-participant glucose responses will be compared across the caffeine, L-citrulline, exogenous ketone, and placebo conditions.
From pre-supplement baseline through completion of the immediate post-exercise assessments at each experimental visit.
Completion of All Four Experimental Visits
Time Frame: Across each participant's approximately 4-6 weeks of study participation.

Feasibility will be assessed by the number and proportion of enrolled participants who complete all four randomized experimental visits and the full four-condition crossover protocol.
Across each participant's approximately 4-6 weeks of study participation.
Participants Experiencing Adverse Events
Time Frame: From the first study visit through completion of the final study visit, approximately 4-6 weeks per participant.

Adverse events and adverse responses occurring in association with study supplementation or exercise testing will be recorded throughout study participation. The number and proportion of participants experiencing one or more adverse events will be summarized.
From the first study visit through completion of the final study visit, approximately 4-6 weeks per participant.

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.
St. Louis University

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: Hossein Rafiei, St. Louis University

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 (Estimated)

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.
October 1, 2026

Primary Completion (Estimated)

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 1, 2027

Study Completion (Estimated)

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.
August 1, 2027

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).
September 26, 2026

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.
September 26, 2026

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.
October 2, 2026

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.
October 2, 2026

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.
September 26, 2026

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.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • STUDY00000697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with outside researchers. Only de-identified, aggregate study results may be used for analysis, publication, or presentation, in accordance with the approved protocol and participant privacy protections.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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