Clinical Trial

Program Protocol for a Population That Works in Conditions of Hypobaric Hypoxia

Enrolling by Invitation Early Phase 1
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Summary
The objective of this randomized, longitudinal, single-blind, two-group parallel clinical trial is to evaluate the effect of a physical exercise and nutritional protocol on the health determinants of workers performing their work shift under hypobaric hypoxia conditions at 2,950 meters above sea level (masl) and to determine whether these interventions contribute to improving their health. For this study, initial assessments of body composition, physical fitness tests, gut microbiota analysis, blood inflammatory markers, and quality of life surveys will be conducted on all subjects during the first and last day of their work shift at 2,950 masl. Subsequently, they will be divided into two groups. Subjects in Group 1 (G1) will follow the same guided exercise protocol along with a nutritional plan designed by the research team. Those in Group 2 (G2) will undergo guided physical training for the seven days they are working under hypobaric hypoxia conditions. Finally, the results of the analyses between time 1 and time 2 will be compared, in addition to intra-group evaluations
Trial Details
NCT Number NCT07624409
Lead Sponsor Jorge Torres Mejías
Conditions Changes in the Intestinal Microbiota Under Hypobaric Hypoxia Conditions, Changes in Blood Glucose Under Hypobaric Hypoxia Conditions, Changes in Body Composition Under Hypobaric Hypoxia Conditions, Determination of Physiological Stress in Hypobaric Hypoxia
Enrollment 22 participants
Start Date 2026-07-01
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-03