Healthy Normal AthletesNCT07102680
A Randomized, Placebo Controlled Trial of L Max in Healthy Adult Athletes
A study testing L Max in people with Healthy Normal Athletes, run by Climatic, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Normal Athletes
- What is being tested?
- L Max
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2026to 13 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMIZED PLACEBO CONTROLLED TRIAL OF L MAX IN HEALTHY ADULT ATHLETES
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
- Conditions
- Healthy Normal Athletes
- Being tested
- L Max, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L MaxOther
L Max proprietary formulation
PlaceboOther
Lactohale 300
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to end of treatment at Day 42
Secondary outcomes (2)
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.
Measured: From baseline to end of treatment at Day 42
Percent change from baseline in power output during timed performance test
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 their power output during 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.
Measured: From baseline to end of treatment at Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start19 Jan 2026
- Primary completion21 Jun 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Normal AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Climatic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft Principal Investigator, M.D., Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102680
- Sponsor's protocol ID
- CHI-A2-001
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are part of ongoing research and will not be available for sharing due to potential publication and/or intellectual property considerations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED PLACEBO CONTROLLED TRIAL OF L MAX IN HEALTHY ADULT ATHLETES
- ClinicalTrials.gov ID
- NCT07102680
- Acronym / sponsor ID
- CHI-A2-001
- Conditions
- Healthy Normal Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Climatic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 21 Jun 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L Max Arm | Active comparator | Other: L MaxParticipants 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. |
| Placebo Arm | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L MaxL Max proprietary formulation | Other | L Max Arm |
| PlaceboLactohale 300 | Other | Placebo Arm |
Primary outcome
Change from baseline in Composite PRO Score
Time frame: From baseline to the end of treatment at 42 days
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.
Change from baseline in Composite PRO Question #1
Time frame: From baseline to end of treatment at Day 42
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.
Change from baseline in Composite PRO Question #2
Time frame: From baseline to end of treatment at Day 42
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.
Change from baseline in Composite PRO Question #3
Time frame: From baseline to end of treatment at Day 42
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.
Change from baseline in Composite PRO Question #4
Time frame: From baseline to end of treatment at Day 42
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.
2 secondary outcomes
Percent change from baseline in timed performance test completion time
Time frame: From baseline to end of treatment at Day 42
Percent change from baseline in power output during timed performance test
Time frame: From baseline to end of treatment at Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. The data are part of ongoing research and will not be available for sharing due to potential publication and/or intellectual property considerations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Craft Principal Investigator, M.D. principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L Max in people with Healthy Normal Athletes, run by Climatic, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Composite PRO Score (time frame: From baseline to the end of treatment at 42 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.