A Randomized, Placebo Controlled Trial of L Max in Healthy Adult Athletes

Phase

N/A

Condition

N/A

Treatment

Placebo

L Max

Clinical Study ID

NCT07102680

CHI-A2-001

Ages 18-60
All Genders
Accepts Healthy Volunteers

Study Summary

The goal of this study is to evaluate the lung-cleansing effects of L Max by measuring changes in Participant Reported Outcome (PRO) Scores and athletic performance. Researchers will compare the results of participants who take L Max and participants who take placebo (a look-alike substance that contains no active ingredient).

Participants will:

Wear an Oura Ring continuously throughout the study
Perform spirometry (a measurement of your lung health) daily
Fill out short daily exercise and health logs
Perform three timed athletic performance tests over the course of the study and record the results
Fill out Participant Reported Outcomes Surveys three times over the course of the study
Fill out study product surveys twice over the course of the study
Participate in an optional exit survey at the end of the study

Eligibility Criteria

Inclusion

Inclusion Criteria:

Aged 18 to 60 years
US-based
Committed endurance athlete with cycling, triathlon or running focus
Achieves three or more Zone 3+ sessions/week
Tracks power and time during training
Able to use Oura, spirometry, and training apps
Routinely feels pulmonary system/breathing limits athletic performance
If diagnosed with exercise induce asthma, able to use inhaler only as rescue and notpreventatively.
Women of childbearing potential (WOCBP) must agree to use highly effectivecontraception starting at least 14 days prior to the first dose of L Max or placebo,throughout the study period, and for at least 30 days after the last dose of studyproduct. Highly effective methods include the following: abstinence, oral contraceptives,contraceptive injections, intrauterine device, double barrier method (Diaphragm orcondom + spermicidal cream) contraceptive patch, or male partner sterilization.Women who are postmenopausal (at least 12 months of spontaneous amenorrhea withoutan alternative medical cause) or surgically sterile (e.g. hysterectomy,salpingectomy, bilateral oophorectomy, or bilateral tubal ligation) are notconsidered of childbearing potential.
Willing to practice a reliable method of contraception for the duration of the study
In good general health at the time of screening (Investigator discretion).
Able to read and understand English
Able to read, understand, and provide informed consent
Able to use a personal smartphone device and download Chloe by PeopleScience, Oura,and MIR Spirobank
Able to receive shipment of the product at an address within the United States
Able to complete study assessments over the course of up to 6 weeks.

Exclusion

Exclusion Criteria:

Do not have a personal smartphone, internet access, or are unwilling to downloadChloe, Oura, or MIR Spirobank apps
Daily/preventative inhaler use
Injury, illness, or poor training compliance in the previous 6 months
History of COPD, long COVID, fibromyalgia, chronic fatigue syndrome, Lyme disease,or major cardiac or respiratory conditions
Lack of access to indoor trainer with power meter
High alcohol use or ongoing recreational drug/tobacco use
Pregnant, planning to become pregnant during the study, or lactating
Use of medications to treat hypertension (high blood pressure) including diuretics,Angiotensin Converting Enzyme inhibitors, Angiotensin II Receptor Blockers, calciumchannel blockers, beta blockers, alpha blockers, and other classes used for bloodpressure control
Any underlying medical conditions or comorbidities that may confound the assessmentor the evaluation of the study outcomes.
Have a significant illness, disease, or condition which, in the opinion of theprincipal investigator, may impact their ability to participate in the study orimpact the study outcomes.
Known hypersensitivity or previous allergic reaction to sodium bicarbonate, citrate,theobromine, arginine, forskolin, maltodextrin, modified food starch, or lactose
Are unlikely for any reason to be able to comply with the trial or are consideredunsuited for participation in the study by the Principal Investigator.

Study Design