Clinical trial NCT06358274: Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail
Official title: Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thru-hiking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals hiking The Colorado Trail in its entirety in summer 2024. Excluded are those having hiked another thru-hike 6 months prior.

Brief summary: Thru-hiking the Colorado Trail presents distinct challenges owing to its diverse landscapes and high altitudes. The study aims to delve into the physiological and nutritional facets of extended wilderness trekking among thru-hikers. Activities encompass participant recruitment from the Colorado Trail Foundation community, baseline and post-trail assessments including blood lipid panel analysis and anthropometric measurements, data collection during the trail period involving recording daily mileage, exertion levels, and dietary intake, rigorous statistical analysis to explore correlations among various parameters, and adherence to ethical considerations including obtaining formal approval and ensuring informed consent procedures are followed to safeguard participants' rights and privacy. Through this endeavor, the study seeks to offer insights into the metabolic responses and cardiovascular implications associated with thru-hiking, shedding light on the interplay between diet, lifestyle factors, and metabolic health in challenging environments.

The specific aims include examining the metabolic responses and cardiovascular implications associated with thru-hiking, exploring correlations between dietary intake and blood lipid profiles, and elucidating the interplay between lifestyle factors and metabolic health in demanding environments. This study is not limited to program evaluation, quality assurance, or improvement activities within a specific department or setting but rather seeks to contribute to scientific knowledge and inform evidence-based recommendations for individuals engaging in thru-hiking or similar high-intensity activities.


Eligibility criteria: Inclusion Criteria:

* Thru-Hikers on the Colorado Trail:
* Individuals planning to commence their thru-hiking journey on the Colorado Trail in early July.

Residence:

* Participants must reside in northern Colorado.
* Thru-Hiking History
* Participants must not have completed another thru-hike in the past 6 months.
* Informed Consent
* Individuals interested in participating in the study must provide informed consent.

Exclusion Criteria:

* Individuals who have completed another thru-hike in the past 6 months
* children below the age of majority, pregnant women, fetuses, and neonates
* prisoners, adults lacking the capacity to consent or with fluctuating capacity, non-English speakers, and illiterate individuals
* employees or students of the researcher
* individuals from undervalued or disenfranchised social groups
* Active members of the military, including Department of Defense (DoD) personnel
* individuals in stressful situations, those disadvantaged in social goods and services and individuals with serious health conditions lacking standard treatments
* those with a fear of negative consequences for not participating and individuals facing circumstances increasing vulnerability to coercion or exploitation

Primary outcomes:
measure: blood lipid panel: total cholesterol
timeFrame: baseline and 2 days post-hike
measure: blood lipid panel: high-density lipoprotein (HDL)
timeFrame: baseline and 2 days post-hike
measure: blood lipid panel: low-density lipoprotein (LDL)
timeFrame: baseline and 2 days post-hike
measure: blood lipid panel: triglycerides
timeFrame: baseline and 2 days post-hike
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Stephen Selinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: