Validity of Smart Cap and Smart Sweat Patch

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-08

Study Completion Date

2022-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objectives are to determine the validity of a Smart Cap in measuring fluid intake during running and fitness exercise and the validity of a Smart Sweat Patch in measuring sweat rate and sweat chloride concentration during outdoor cycling, running, and fitness exercise. A secondary objective is to compare regional sweating rate and sweat electrolyte concentrations (sodium, chloride, and potassium) on contralateral arms with vs. without tattoos.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sweat Patch Validation

NCT04240951

Sweat Analysis

COMPLETED NA

NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players

NCT04679532

Sweat Analysis

COMPLETED NA

The Impact of Blood Flow Restriction Within Warm-up.

NCT05153980

Healthy

COMPLETED NA

Arm Compression on Muscle Oxygen Saturation

NCT05037071

Muscle; Fatigue, Heart

COMPLETED NA

The Effect of Remote Preconditioning on the Exercise Performance of the Elite Swimmers

NCT00761566

Healthy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fluid Intake in Athletes Sweating Rate in Athletes Sweat Chloride Concentration in Athletes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Each subject will serve as his or her own control. We will compare the Test and Reference methods during moderate intensity self-paced training runs, coach-led fitness sessions, and/or group outdoor cycling rides.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Smart sweat patch for sweat rate and sweat chloride concentration

Epidermal microfluidic patch that is a flexible 27 cm2 platform with an adhesive backing that collects sweat through a skin-facing inlet port. Custom software uses the smartphone camera to capture and analyze the microfluidic patch.

Group Type EXPERIMENTAL

Sweat Patch, all subjects- running, fitness, cycling

Intervention Type DEVICE

Regional contralateral forearm patch

Reference sweat patch for sweat rate and sweat electrolytes

Regional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography

Group Type PLACEBO_COMPARATOR

Reference sweat patch, all subjects - running, fitness, cycling

Intervention Type DEVICE

Regional contralateral forearm patch

Smart Cap bottle fluid measurement

Fluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection

Group Type EXPERIMENTAL

Smart Cap, running and fitness exercisers only

Intervention Type DEVICE

Bottle cap

Reference method bottle fluid measurement

Scale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists)

Group Type OTHER

Bottle Scale, all subjects - running, fitness, cycling

Intervention Type OTHER

Bottle weight

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Smart Cap, running and fitness exercisers only

Bottle cap

Intervention Type DEVICE

Sweat Patch, all subjects- running, fitness, cycling

Regional contralateral forearm patch

Intervention Type DEVICE

Reference sweat patch, all subjects - running, fitness, cycling

Regional contralateral forearm patch

Intervention Type DEVICE

Bottle Scale, all subjects - running, fitness, cycling

Bottle weight

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject is male or female
* Subject is 16-65 years of age
* Subject is moderately-trained (participates in regular outdoor fitness (\~1 h), cycling (1-2 h), or running (0.5-1 h) sessions ≥2x per week)
* Subject is participating in an instructor-led fitness session, typical training run, or group bicycle ride

Exclusion Criteria

* Subject is pregnant
* Subject is a smoker
* Subject is taking a medication or oral supplement that could interfere with study results
* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)
* Subject has ≥ 2 cardiovascular risk factors as assessed on the General Health History Questionnaire
* Subject has participated in a clinical trial within past 30 days
* Subject has participated in any PepsiCo trial within past 6 months
* Subject has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk
* 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 products. 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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes