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

Official title

Physical and Nutritional Exercise Program Protocol for the Improvement of the Health Determinants of a Population That Works in Conditions of Intermittent Hypobaric Hypoxia

Overview

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

Detailed description

This study is an investigation that seeks to evaluate the effect of a physical exercise and nutritional protocol on the determinants of health (nutritional status and body composition, metabolic-inflammatory parameters, glucose profile, gut microbiome, physical condition, autonomic nervous system, and sleep patterns) of workers who perform their workday at an astronomical observatory under hypobaric hypoxia conditions between 2,950 and 5,050 meters above sea level. The objective of this intervention is to standardize both physical and nutritional recommendations for this type of worker under intermittent hypobaric hypoxia conditions.

The procedure will begin by incorporating personnel who meet the inclusion criteria: (being an employee contracted by the ALMA Observatory with more than one year of seniority, working in AOS or OSF sectors of the observatory, and not suffering from non-communicable diseases such as type 2 diabetes or hypertension). On the other hand, the exclusion criteria for this research are: people who use pacemakers, those who are temporarily stationed at the facilities, and pregnant women. Once the "n" of 11 subjects for each research group has been obtained, all participants will undergo a nutritional and body composition assessment by a registered dietitian. This assessment will utilize a multifrequency bioimpedance analysis (BIA) device, model INBODY 270S. Participants will be asked to come to the designated laboratory after fasting for 4 hours and removing as much clothing as possible, including shoes, socks, and any metal jewelry. The analysis will consist of weighing the participant in kilograms and measuring their height (SECA 700 scale). Subsequently, waist and hip circumferences will be measured using a SECA 201 ergonomic measuring tape. To complete the nutritional assessment, participants will be asked to step onto the BIA device barefoot, where they will place the hand electrodes and follow the evaluation instructions provided by the device. Subsequently, a Polar H10 elastic heart rate monitor will be fitted to the chest area and connected to the Polar Beat app for continuous heart rate monitoring. Along with this heart rate monitor, each participant will also have an Actigraph WG3XBT elastic heart rate monitor fitted to their hip area to measure the intensity of their movements. To determine the physical condition and estimate the VO2max of the subjects under study, all will undergo a Modified Queens College box test, in a 20 cm high box for a period of 3 minutes. Finally, a Freestyle Libre 2 Plus continuous glucose monitoring patch will be fitted to the left triceps. These individually fitted devices will continue to collect data for 14 consecutive days. Once the entire installation phase is complete, each participant will be given two sealed, sterilized plastic containers. In these containers, they must provide the research team with two small fecal samples (one on the day of arrival at the observatory and another on the last day of their stay). These samples will be processed in the laboratory set up for this purpose at the observatory using a QIAamp PowerFecal Pro DNA Kit. A DNA sample will be extracted following the kit's instructions, then frozen and transported to the University facilities. There, the samples will be processed using a DNA sequencing system. They will be stored in the buffer included with the aforementioned extraction kit and subsequently frozen in a special -20°C refrigerator at the GEMA laboratory for later analysis. The samples will then be analyzed using an Invitrogen Qubit fluorometer to quantify the concentration of extracted DNA. Subsequently, the samples will be analyzed using capillary electrophoresis on a Bioptic Fragment Analyzer™ (QSep 1). Following this, the libraries will be prepared according to the sequencer to be used, and sequencing will then begin on an Illumina MiSeq and/or Nanopore MinION platform (depending on the number of DNA samples extracted and the amount of data to be sequenced).

In addition, a trained paramedic will collect 5 ml of venous blood, which will be placed in polypropylene tubes with anticoagulant and centrifuged at 3000 rpm. The plasma and blood will then be sent refrigerated to the CEIMA laboratory at Arturo Prat University for analysis and quantification of inflammatory factors using the SOD Colorimeter Activity Kit and the GSH-PX Activity Kit, following the respective manufacturers' instructions.

Once the initial analyses are complete, the study subjects will be divided into two groups:

G1 (Intervention group with resistance training and nutritional supplementation) This group will undergo a resistance training program guided by a physical activity professional for three days during their work shift, along with a daily intake of a probiotic and prebiotic supplement for seven days. To this end, the maximum number of repetitions (1RM) that the individual can perform for each of the four muscle groups will be calculated at the beginning. Therefore, 3 sets of 10 repetitions each will be performed for the following muscle groups: 1. biceps, 2. quadriceps, 3. pectorals, and 4. gastrocnemius, at 50% of the previously calculated maximum repetition.

In addition, this group's diet will be supplemented with the administration of two "Karún Life" brand probiotic tablets for the seven days of the work shift.

G2 (Overload Physical Exercise Intervention Group) This group will undergo the same overload training program as the previous group under the same conditions mentioned above.

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 pre
• 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
• 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

Primary outcome measures

• Aerobic Fitness, (ml/kg/min oxygen utilization) [Time frame: day 1 and 7 of the work shift]
• Glucose Curve (mg/dl) [Time frame: from the beginning of the work shift up to 14 consecutive days]
• Body Composition (%fat mass, %free fat mass, %total body water) [Time frame: day 1 and 7 of the work shift]
• Food surveys [Time frame: day 2 of the work shift]
• Evaluation of movement intensity (METS/hora) [Time frame: from day 1 of the work shift to day 14]
• Heart Rate Quantification [Time frame: from day 1 of the work shift to day 14]
• Muscle Strength (1RM) [Time frame: Day 1 of the work shift and day 7 of the shift]

Secondary outcome measures (1)

• Cardiac Variability [Time frame: Day 1 of the work shift and day 7 of the shift]

Eligibility criteria

Inclusion criteria

• Be an employee of the ALMA Observatory, Chile.
• Reside in the AOS (5,000 m above sea level) or OSF (2,950 m above sea level) sectors.
• Have more than one year of employment history.

Exclusion criteria

• Individuals with pacemakers.
• Individuals only temporarily residing in observatory areas located in the Antofagasta Region.
• Pregnant women.
• Individuals with metal implants.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Chile · 1 center

• Observatorio ALMA — San Pedro de Atacama

Publications

• Torres-Mejias J, Arriaza K, Mena F, Rivarola E, Paredes P, Ahmad H, Lopez I, Soza D, Pino-Villalon JL, Lopez-Espinoza MA, Duran-Aguero S, Merellano-Navarro E. Body Composition, Microbiome and Physical Activity in Workers Under Intermittent Hypobaric Hypoxia. Nutrients. 2025 Dec 15;17(24):3919. doi: 10.3390/nu17243919. PMID 41470864
• Su Q, Zhuang DH, Li YC, Chen Y, Wang XY, Ge MX, Xue TY, Zhang QY, Liu XY, Yin FQ, Han YM, Gao ZL, Zhao L, Li YX, Lv MJ, Yang LQ, Xia TR, Luo YJ, Zhang Z, Kong QP. Gut microbiota contributes to high-altitude hypoxia acclimatization of human populations. Genome Biol. 2024 Aug 28;25(1):232. doi: 10.1186/s13059-024-03373-w. PMID 39198826
• Shanahan F, Ghosh TS, O'Toole PW. The Healthy Microbiome-What Is the Definition of a Healthy Gut Microbiome? Gastroenterology. 2021 Jan;160(2):483-494. doi: 10.1053/j.gastro.2020.09.057. Epub 2020 Nov 27. PMID 33253682
• Nishimura T, Motoi M, Toyoshima H, Kishida F, Shin S, Katsumura T, Nakayama K, Oota H, Higuchi S, Watanuki S, Maeda T. Endocrine, inflammatory and immune responses and individual differences in acute hypobaric hypoxia in lowlanders. Sci Rep. 2023 Aug 4;13(1):12659. doi: 10.1038/s41598-023-39894-w. PMID 37542110
• Nathan NN, Philpott DJ, Girardin SE. The intestinal microbiota: from health to disease, and back. Microbes Infect. 2021 Jul-Aug;23(6-7):104849. doi: 10.1016/j.micinf.2021.104849. Epub 2021 Jun 17. PMID 34146716
• Mallet RT, Burtscher J, Pialoux V, Pasha Q, Ahmad Y, Millet GP, Burtscher M. Molecular Mechanisms of High-Altitude Acclimatization. Int J Mol Sci. 2023 Jan 15;24(2):1698. doi: 10.3390/ijms24021698. PMID 36675214
• Liu D, Chen D, Xiao J, Wang W, Zhang LJ, Peng H, Han C, Yao H. High-altitude-induced alterations in intestinal microbiota. Front Microbiol. 2024 May 9;15:1369627. doi: 10.3389/fmicb.2024.1369627. eCollection 2024. PMID 38784803
• Li L, Zhou Y, Zou S, Wang Y. The Effects of High-Altitude Mountaineering on Cognitive Function in Mountaineers: A Meta-Analysis. Int J Environ Res Public Health. 2023 Mar 14;20(6):5101. doi: 10.3390/ijerph20065101. PMID 36982007

Identifiers

NCT: NCT07624409 · CIAAG09/2026UCM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗