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Heart Rate VariabilityNCT06964100

Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Endurance Performance

An observational study of Heart Rate Variability, run by PepsiCo Global R&D at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The ability of smart phones, aided by wearable devices (e.g. smart watches), to collect a variety of data, including physical activity, heart rate, and other exercise metrics, may provide a unique opportunity to understand real-world variability. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Heart Rate Variability
How many people
200 participants
Where
1 siteUnited States
Study dates
4 Apr 2025to 30 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy volunteers ages 8-65, actively participating in cardiovascular training (3-5 days/week), able to run a 5K (3.1 miles) distance at a self-selected location, three times over 8 weeks, wear an activity tracker and willing to use the study smartphone app.

Who may be able to join

  • Actively participating in cardiovascular training (3-5 days/week).
  • Able to run a 5K (3.1 miles) distance at a self-selected location, three times over 8 weeks.
  • Age 18-65 years.
  • Subject is willing to refrain from vigorous exercise (light physical activity only) 24 hours prior to timed 5K assessment.
  • Subject is willing to avoid alcohol consumption 24 hours prior to 5K assessment.
  • Subject is willing to provide consent.
  • Subject is able to continuously wear their activity tracker, including during sleep, except when submerged underwater (i.e., swimming, bathing).
  • Subjects must have compatible wearable device (Android, Apple Health, Dexcom, Fitbit, Garmin, Health Connect, Oura, Polar, Whoop, and Withings).

Who cannot join

  • Individual has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the project/study protocol, which might confound the interpretation of the project/study results or put the person at undue risk.
  • Those with a medical history that would interfere with the results of this study.
  • Those that have ≥1 risk factor for cardiovascular disease according to the American College of Sports Medicine.
  • Age: Men ≥ 45 yrs; Women ≥ 55 yrs.
  • Family History: Heart attack, "bypass surgery", or sudden death before the age of 55 yrs for father/brother, or before 65 yrs for mother/sister.
  • Cigarette Smoking: Current smoker, or have quit < 6 months, or exposed to environmental smoke.
Show all 20Show fewer
  • Sedentary lifestyle: Not participating in moderate (sweating) physical activity at least 3 days/week for 3-months.
  • Obesity: Body mass index ≥ 30 kg/m2 or waist girth 102 cm (40 inches) for men and 88 cm (35 inches) for women.
  • Hypertension: Systolic Blood Pressure ≥ 140 mmHg and/or Diastolic ≥90 mmHg, or taking medication.
  • Dyslipidemia: LDL ≥130 mg/dl, or HDL < 40 mg/dl, or taking medication. Or triglycerides (TG) > 200 > mg/dl.
  • Pre-diabetes: Impaired fasting glucose (IFG) ≥ 100 mg/dl or oral glucose tolerance test (OGTT) ≥ 140 or ≤ 199 mg/dl confirmed by two different measurements.
  • Under the care of a physician.
  • Sleep disorders.
  • Using prescription medications that would impact sleep.
  • If female, you are not pregnant, planning to get pregnant or currently breast feeding.
  • Not able to wear activity tracker continuously.
  • Lack of proficiency in English.
  • Lack of proficiency or access to the internet and email address.
  • Participation in another clinical trial within the past 30 days.
  • Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Remote study, no physical site. Managed by Gatorade Sports Science Institute. Do not contact investigators to enroll. Recruitment is handled by an independent agency.

    Chicago, Illinois, 60607

Other trials in United States

About this study

The ability of smart phones, aided by wearable devices (e.g. smart watches), to collect a variety of data, including physical activity, heart rate, and other exercise metrics, may provide a unique opportunity to understand real-world variability. The primary objective of this study is to test user engagement, app functionality, and feasibility of the newly developed Gatorade Sports Science Institute (GSSI) Labs App to conduct Real-World research studies. The secondary purpose of this study is to determine if Training Intensity (%Heart Rate maximum) in minutes during low heart rate variability (HRV) periods (below HRV baseline consecutive days) will have a negative relationship with post-study 5K (5 kilometer) running times as measured by their activity tracker, which could lead to personalized training recommendations using HRV. This study is conducted remotely, there are no in-person visits.

Read the detailed description

Heart rate variability (HRV) is an indirect biomarker of an individual's performance readiness and recovery. HRV is a ubiquitous biomarker measured by most consumer-grade wearable fitness trackers. However, there is little documented on the relationship between HRV, training load, and performance measures in the Real-World. Using activity trackers to monitor multiple physiological and subjective measures of health and wellness, subjects will perform self-administered 5 kilometer (5K) timed runs on Week 1, Week 4, and Week 8. Users will be instructed to run their 5K (3.1 miles) on the same outdoor course, indoor track, or treadmill to provide consistency in their performance assessments, with the understanding that there will be some limitations in creating a consistent performance assessment environment (i.e.; weather).

Keywords
heart rate variability, HRV, real world, activity tracker, app engagement, app functionality, remote

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. User engagement with Gatorade Sports Science Institute (GSSI) Labs app

    Percent (%) who complete enrollment, informed consent form (ICF), demographics, sync biometrics, complete journal entries, 5 kilometer (5K) performance assessment, and complete study

    Measured: From activating app through study Week 8

Secondary outcomes (6)

  1. Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Heart rate variability (HRV)

    Fluctuation in the amount of time between heartbeats in milliseconds (ms)

    Measured: Week 1 baseline, Week 4 and Week 8

  2. Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Resting heart rate (RHR)

    Heart rate at rest in beats per minute (bpm)

    Measured: Week 1 baseline, Week 4 and Week 8

  3. Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Quantity

    Sleep at night in minutes

    Measured: Week 1 baseline, Week 4 and Week 8

  4. Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Efficiency

    Percentage (%) of time spent asleep while in bed, calculated by dividing total sleep time by time in bed in hours

    Measured: Week 1 baseline, Week 4 and Week 8

  5. Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Sleep Consistency

    Percent (%) of consistency in sleep-wake schedule

    Measured: Week 1 baseline, Week 4 and Week 8

  6. Pre-, Mid-, and Post-5K run times and wearable activity tracker biometrics: Training Zones Percent (%) maximum heart rate (HRmax) in minutes

    Heart rate training zones from Zone 1 (Very Light/Recovery): 50-60 percent (%) of maximum heart rate (HR) to Zone 5 (Very Hard/Maximum): 90-100% of max HR, in minutes (min)

    Measured: Week 1 baseline, Week 4 and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start4 Apr 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06964100
Sponsor's protocol ID
PEP-2502
Status last verified
Sep 2026
First submitted
15 Apr 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Rate Variability, run by PepsiCo Global R&D at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User engagement with Gatorade Sports Science Institute (GSSI) Labs app (time frame: From activating app through study Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06964100.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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