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

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

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

Interventions

DIETARY_SUPPLEMENT

Probiotic Nutritional Intervention

The entire group will be supplemented with a known dose of 2 tablets daily of the probiotic "Karún Life" for 2 weeks (during the work week and the subsequent week of rest).

OTHER

Overload Exercise Protocol

On the first day of sampling, muscle strength will be evaluated using arm and back dynamometry. Along with this, "the maximum repetition" (1RM) of the pectoral, quadriceps, biceps and gastrocnemius muscle groups will be determined, with their values recorded on the record. Subsequently, an exercise protocol will be carried out during day 2-4-6 of the work day, using eccentric muscle contraction exercises, with 50% of the maximum weight achieved in the initial tests, in the same muscle groups previously evaluated, through 3 series with 10 repetitions each. ending the intervention with a new dynamometry evaluation of the arms, back and MRI in these muscle groups.

DEVICE

Bioimpedanciometry

Determination of body composition and phase angle in both intervention groups (G1 and G2), during day one of the beginning of the work shift and the last day, both under conditions of intermittent hypobaric hypoxia. For which, the subjects will be placed with as little clothing as possible, without any metal on the body, with bare feet on the InBody Bioimpedancemeter, Model: 270S., with which fat mass, fat-free mass, total body water, intracellular water, extracellular water and phase angle will be calculated.

DEVICE

heart rate

A heart rate monitor belt, POLAR brand, model H10, will be installed on all subjects in both groups, for 14 continuous days (seven days in conditions of hypobaric hypoxia and 7 days in normobaric conditions), equipment that will remain connected to the accelerometer that the participants will have, in order to record their heart rate along with the intensity of movement.

DEVICE

continuous glucose analysis

On the first day after the start of the work shift, a FreeStyle brand continuous glucose measurement patch will be installed in the area of the right triceps, which will be removed on the 14th (after the return of a new work shift), with which it is expected to know the glucose curves of people who perform work under conditions of intermittent hypobaric hypoxia between 2950 meters above sea level and 5050 meters above sea level.

BIOLOGICAL

gut microbiota analysis

A small sample of feces will be requested from each individual on day 1 at the start of the work shift and on day 7 at the end of the shift. Bacterial DNA will be extracted from these samples according to the manufacturer's protocol (QIAGEN\_QIAamp PowerFecal Pro DNA Kit), which will be frozen to be sent to the GEMA laboratory of the Catholic University of Maule, where they will be sequenced in a Bioptic Fragment Analyzer processor (QSep 1).

DEVICE

Accelerometer

On the first day of the start of the work shift, an elastic belt with an Actigraph brand accelerometer, model wgt3x-bt, will be installed, which will be attached to the body on the right hip of each subject under study. This device will be removed on the 14th day of use, with which it is expected to quantify the intensity of the subject's movement, both during their work days and days of rest (between 2950 meters above sea level and 5050 meters above sea level).

OTHER

Evaluation of sleep quality, using the Pittsburgh survey

A private survey will be carried out with each of the subjects being evaluated, using a survey to determine the quality of sleep of each person in conditions of intermittent hypobaric hypoxia called the Pittsburg Scale, an activity that will be carried out on a single occasion, during the work shift.

OTHER

Quality of life survey SF36 v2.

Like the other surveys, we will use the SF32 V2 survey to develop the level of quality of life of each evaluated subject. This survey will be carried out privately, with an ONLINE questionnaire only once during the work shift.

PROCEDURE

Cardiac Variability Determination

During the first day of stay in conditions of hypobaric hypoxia, taking advantage of the H10 heart rate monitor installed in each subject together with the KUBIOS HRV application and an OMROM blood pressure meter, the evaluation of cardiac variability will be carried out, an activity that will be carried out in the clinic adapted for this work, for which, a time outside of work will be organized, during a rest time, (due to the protocol of the test). This evaluation is secondary to the study

PROCEDURE

VO2 max estimate

During the initial physical evaluations, you will undergo a physical test called the modified Queens Box, (in a 20 cm high box with a test duration of 3 minutes), in which the person must step up to the box and down from it in pulses of 96 per minute for men and 88 for women. The pulses obtained by the subject evaluated using the installed Polar H10 heart rate monitor will be recorded on a record at the end of the test, at minute 1, 2 and 3 once the test is finished.

OTHER

Encuesta alimentaria

During a day different from the initial evaluations, two personal surveys related to diet will be carried out on each study subject, which will be carried out by a qualified nutritionist professional. These surveys will provide valuable information on the eating habits of the study subjects during their working hours under conditions of hypobaric hypoxia and during their rest days.

Sponsors & Collaborators

• Jorge Torres Mejías

  lead OTHER

Principal Investigators

• jorge H Torres Mejías, Magister · Centro de Investigación Andino para la Altitud Geográfica

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2026-08-30

Completion

2026-12-30

Countries

• Chile

Study Locations