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Search / Trial NCT06964100

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

Launched by PEPSICO GLOBAL R&D · Apr 30, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Heart Rate Variability Hrv Real World Activity Tracker App Engagement App Functionality Remote

ClinConnect Summary

This clinical trial is studying how heart rate variability (HRV) relates to training load and endurance performance, specifically looking at how different training intensities affect running times. The researchers are using a new app developed by the Gatorade Sports Science Institute to gather information from participants who will wear activity trackers. The goal is to see if low HRV during training could negatively impact running performance, which could help create personalized training plans in the future.

To participate, you need to be between 18 and 65 years old, actively training for cardiovascular fitness at least three days a week, and able to run a 5K distance three times within eight weeks. You'll also need to wear an activity tracker continuously, except when swimming or bathing. The study is done remotely, meaning you won't need to go to any in-person appointments. Participants will be asked to avoid intense exercise and alcohol for 24 hours before their timed 5K run. If you’re interested in helping improve training methods and meet the eligibility requirements, this could be a great opportunity!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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).
  • Exclusion Criteria:
  • 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.
  • 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.

About Pepsico Global R&D

PepsiCo Global R&D is a leading innovator in the food and beverage industry, dedicated to advancing the science of nutrition and product development. With a strong focus on health and wellness, the organization conducts rigorous clinical trials to explore the efficacy and safety of its products, aiming to enhance consumer experiences while promoting sustainable practices. Leveraging cutting-edge research methodologies and a multidisciplinary approach, PepsiCo Global R&D collaborates with academic institutions and healthcare professionals to drive evidence-based advancements in nutrition, ensuring that its offerings meet the evolving needs of consumers worldwide.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Corey Ungaro, do not contact to enroll, PhD

Principal Investigator

PepsiCo R&D Life Sciences, Sports Science

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported