A Randomized, Placebo Controlled Trial of L Max in Health... | NCT07102680

NCT07102680

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
People Science	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
L Max Arm	Active Comparator	Participants will complete up to a ten week study consisting of screening period, pre-study preparation period, baseline period, a 4-week product use period. Screening assessments, baseline questions, participant reported outcome surveys, exercise, health, and dosing logs, and adverse event reporting will be collected. Participants will have the option of participating in an end of study interview. This study will be conducted remotely and will use a web-based data collection platform, Consumer Health Learning and Organizing Ecosystem (Chloe), by People Science where participants will complete study assessments using the Chloe app during the course of the study. Participants will receive the study product during the pre-study preparation period. Demographic and limited medical history data will be collected for the study.	Other: L Max
Placebo Arm	Placebo Comparator	Participants will complete up to a ten week study consisting of screening period, pre-study preparation period, baseline period, a 4-week product use period. Screening assessments, baseline questions, participant reported outcome surveys, exercise, health, and dosing logs, and adverse event reporting will be collected. Participants will have the option of participating in an end of study interview. This study will be conducted remotely and will use a web-based data collection platform, Consumer Health Learning and Organizing Ecosystem (Chloe), by People Science where participants will complete study assessments using the Chloe app during the course of the study. Participants will receive the study product during the pre-study preparation period. Demographic and limited medical history data will be collected for the study.	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
L Max	Other	L Max proprietary formulation	L Max Arm
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Composite PRO Score	Change from baseline between placebo and study groups of the Composite PRO score. Composite PRO is comprised of 4 questions related to the participant's experience during Zone 3+ workouts. Score ranges from 9 to 45, higher scores indicating better outcome.	From baseline to the end of treatment at 42 days
Change from baseline in Composite PRO Question #1	Change from baseline between placebo and study groups on question #1: Over the past two weeks, how would you rate any changes in your breathing, congestion, or overall lung health during high-intensity workouts (Zone 3+) compared to your normal baseline? Score ranges from 1 to 5, higher score indicating better outcome.	From baseline to end of treatment at Day 42
Change from baseline in Composite PRO Question #2	Change from baseline between placebo and study groups on question #2: Over the past two weeks, how would you rate your ease of breathing during high-intensity workouts (Zone 3+)? Score ranges from 1 to 5, higher score indicating better outcome.	From baseline to end of treatment at Day 42
Change from baseline in Composite PRO Question #3	Change from baseline between placebo and study groups on question #3: Over the past two weeks, how often do you experience the following during high-intensity workouts (Zone 3+): Shortness of breath, Chest tightness, Wheezing, Coughing, Fatigue or difficulty maintaining intensity, Phlegm or mucus buildup? Scores range from 1 to 5 for each element, higher score indicating better outcome.	From baseline to end of treatment at Day 42
Change from baseline in Composite PRO Question #4	Change from baseline between placebo and study groups on question #4: Over the last two weeks, how would you rate your ability to push yourself during high-intensity workouts (Zone 3+)? Score ranges from 1 to 5, higher number indicating better outcome.

Secondary Outcomes

Measure	Description	Time Frame
Percent change from baseline in timed performance test completion time	Percent change from baseline between placebo and study groups on a timed performance test. The timed performance test will be either a 5k run or 5 mi cycle on an indoor trainer. Participants will focus on all-out effort and will record the time it takes to complete the performance test. The performance test will be completed at baseline and at 2 weeks and 4 weeks of study participation. A faster performance time will indicate improvement.

Eligibility Module

Eligibility Criteria

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 not preventatively.
Women of childbearing potential (WOCBP) must agree to use highly effective contraception 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 study product.

Highly effective methods include the following: abstinence, oral contraceptives, contraceptive injections, intrauterine device, double barrier method (Diaphragm or condom + spermicidal cream) contraceptive patch, or male partner sterilization. Women who are postmenopausal (at least 12 months of spontaneous amenorrhea without an alternative medical cause) or surgically sterile (e.g. hysterectomy, salpingectomy, bilateral oophorectomy, or bilateral tubal ligation) are not considered 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 Criteria:

Do not have a personal smartphone, internet access, or are unwilling to download Chloe, 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, calcium channel blockers, beta blockers, alpha blockers, and other classes used for blood pressure control
Any underlying medical conditions or comorbidities that may confound the assessment or the evaluation of the study outcomes.
Have a significant illness, disease, or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact 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 considered unsuited for participation in the study by the Principal Investigator.