Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552806
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2023-07-06
Brief Title:
The Effect of a Multi-strain Probiotic on Acclimatization to High Altitude
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of a Multi-strain Probiotic SLAB51 Sivomixx800 on Acclimatization to High Altitude
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn if the probiotic SLAB51 Sivomixx800 works to enhance acclimatization to high altitude in humans The main questions it aims to answer are
Does SLAB51 improve oxygen saturation during high-altitude exposure Researchers will compare SLAB51 to a placebo a substance that contains no probiotic to see if SLAB51 works to enhance high-altitude acclimatization
Participants will
Take SLAB51 or a placebo three times daily during two separate three-night acclimatization periods at high altitude spaced at least six weeks apart
Complete baseline measurements at sea level Visit the high-altitude Barcroft Station 3801 m at the University of California White Mountain Research Center for physiological measurements and assessments
Undergo assessments including oxygen saturation ventilation heart rate blood pressure sleep studies cognitive assessments exercise capacity Acute Mountain Sickness scores and provide blood fecal and urine samples for advanced analyses
Does SLAB51 improve oxygen saturation during high-altitude exposure Researchers will compare SLAB51 to a placebo a substance that contains no probiotic to see if SLAB51 works to enhance high-altitude acclimatization
Participants will
Take SLAB51 or a placebo three times daily during two separate three-night acclimatization periods at high altitude spaced at least six weeks apart
Complete baseline measurements at sea level Visit the high-altitude Barcroft Station 3801 m at the University of California White Mountain Research Center for physiological measurements and assessments
Undergo assessments including oxygen saturation ventilation heart rate blood pressure sleep studies cognitive assessments exercise capacity Acute Mountain Sickness scores and provide blood fecal and urine samples for advanced analyses
Detailed Description:
Individuals will be recruited to participate in a double-blind placebo controlled cross-over study receiving placebo or the nutritional supplement probiotic SLAB51 Sivomixx800 during exposure to high altitude to test the effects of SLAB51 on high-altitude acclimatization
Humans face significant physiological detriments when they ascend to high altitude due to hypobaric hypoxia and physiological changes are crucial for acclimatization to this stressful environment Currently there are limited interventions to improve acclimatization to high altitude The investigators conducting this study will test if the probiotic SLAB51 improves oxygen saturation and mitigates negative outcomes often experienced during acclimatization to high altitude through studies performed at sea level and at the high-altitude Barcroft Station 3801 m at the University of California White Mountain Research Center
Preliminary studies indicate that ingestion of SLAB51 significantly improves oxygenation in humans during physical exercise in simulated altitude within a hypobaric chamber in a pressurized airplane cabin during commercial flight in premature born babies and in COVID-19 patients Here the investigators explore whether ingestion of SLAB51 affects acclimatization to high altitude in healthy humans Physiological measurements include oxygen saturation O2 Sat or SpO2 during wakefulness and sleep primary outcomes as well as ventilation heart rate blood pressure sleep studies cognitive assessments exercise capacity measurement of the Acute Mountain Sickness score and the collection of blood fecal and urine samples to further explored through transcriptomics methylation metabolomics and proteomics All measurements will be taken in up to 60 participants on two separate occasions separated by at least 6 weeks Participants will complete all assessments one baseline measurement obtained at sea level 0 - 300 m and then twice during three-night acclimatization periods at Barcroft Station 3801 m At high altitude participants will receive a treatment placebo or SLAB51 upon arrival at Barcroft Station and then three times a day until departure from the high-altitude site During the second portion of the study approximately six weeks later participants will complete the same repeat assessments during a second three-night visit at Barcroft Station where they will receive whichever treatment was not taken during the high-altitude exposure six weeks prior Both participants and researchers performing the studies will be blinded to the treatment Upon completion of the study researchers will compare how participants acclimatized when they received SLAB51 versus when they received the placebo treatment
Humans face significant physiological detriments when they ascend to high altitude due to hypobaric hypoxia and physiological changes are crucial for acclimatization to this stressful environment Currently there are limited interventions to improve acclimatization to high altitude The investigators conducting this study will test if the probiotic SLAB51 improves oxygen saturation and mitigates negative outcomes often experienced during acclimatization to high altitude through studies performed at sea level and at the high-altitude Barcroft Station 3801 m at the University of California White Mountain Research Center
Preliminary studies indicate that ingestion of SLAB51 significantly improves oxygenation in humans during physical exercise in simulated altitude within a hypobaric chamber in a pressurized airplane cabin during commercial flight in premature born babies and in COVID-19 patients Here the investigators explore whether ingestion of SLAB51 affects acclimatization to high altitude in healthy humans Physiological measurements include oxygen saturation O2 Sat or SpO2 during wakefulness and sleep primary outcomes as well as ventilation heart rate blood pressure sleep studies cognitive assessments exercise capacity measurement of the Acute Mountain Sickness score and the collection of blood fecal and urine samples to further explored through transcriptomics methylation metabolomics and proteomics All measurements will be taken in up to 60 participants on two separate occasions separated by at least 6 weeks Participants will complete all assessments one baseline measurement obtained at sea level 0 - 300 m and then twice during three-night acclimatization periods at Barcroft Station 3801 m At high altitude participants will receive a treatment placebo or SLAB51 upon arrival at Barcroft Station and then three times a day until departure from the high-altitude site During the second portion of the study approximately six weeks later participants will complete the same repeat assessments during a second three-night visit at Barcroft Station where they will receive whichever treatment was not taken during the high-altitude exposure six weeks prior Both participants and researchers performing the studies will be blinded to the treatment Upon completion of the study researchers will compare how participants acclimatized when they received SLAB51 versus when they received the placebo treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None