Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06964100

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

Led by PepsiCo Global R&D · Updated on 2025-05-09

200

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Actively participating in cardiovascular training 3 to 5 days per week
  • Able to run a 5K (3.1 miles) distance at a self-selected location three times over 8 weeks
  • Age between 18 and 65 years
  • Willing to avoid vigorous exercise 24 hours before timed 5K assessments
  • Willing to avoid alcohol consumption 24 hours before 5K assessments
  • Willing to provide informed consent
  • Able to continuously wear a compatible activity tracker, including during sleep, except underwater
  • Must have a compatible wearable device such as Android, Apple Health, Dexcom, Fitbit, Garmin, Health Connect, Oura, Polar, Whoop, or Withings
Not Eligible

You will not qualify if you...

  • Condition that interferes with informed consent, study compliance, or study results as judged by Investigator
  • Medical history interfering with study results
  • One or more cardiovascular disease risk factors per American College of Sports Medicine
  • Men aged 45 years or older; women aged 55 years or older
  • Family history of early heart attack, bypass surgery, or sudden death
  • Current smoker or quit less than 6 months ago or exposed to environmental smoke
  • Sedentary lifestyle: less than 3 days/week moderate physical activity for 3 months
  • Obesity: BMI 30 kg/m2 or higher or waist size over 102 cm for men, 88 cm for women
  • Hypertension: systolic ≥140 mmHg or diastolic ≥90 mmHg, or on medication
  • Dyslipidemia: LDL ≥130 mg/dl, HDL <40 mg/dl, triglycerides >200 mg/dl, or on medication
  • Pre-diabetes confirmed by blood glucose tests
  • Under physician care
  • Sleep disorders or use of medications affecting sleep
  • If female, pregnant, planning pregnancy, or breastfeeding
  • Unable to wear activity tracker continuously
  • Not proficient in English or no internet/email access
  • Participated in another clinical trial in past 30 days
  • Employment or family employment with companies competing with Gatorade products

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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, United States, 60607

Actively Recruiting

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Research Team

C

Corey Ungaro, do not contact to enroll, PhD

CONTACT

E

Eric Freese, do not contact to enroll, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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