People Science, Inc.
Los Angeles, California, 90034, United States
NCT Number: NCT07102680
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:
1. Wear an Oura Ring continuously throughout the study 2. Perform spirometry (a measurement of your lung health) daily 3. Fill out short daily exercise and health logs 4. Perform three timed athletic performance tests over the course of the study and record the results 5. Fill out Participant Reported Outcomes Surveys three times over the course of the study 6. Fill out study product surveys twice over the course of the study 7. Participate in an optional exit survey at the end of the study
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90034, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
L Max proprietary formulation
Lactohale 300
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.
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.
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.
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.
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.
Time frame: From baseline to end of treatment at Day 42
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.
Time frame: From baseline to end of treatment at Day 42
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.
Climatic, Inc.
Industry
A RANDOMIZED PLACEBO CONTROLLED TRIAL OF L MAX IN HEALTHY ADULT ATHLETES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.