Thru-hikingNCT06358274
Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail
An observational study of Thru-hiking, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thru-hiking
- What is being tested?
- Thru-hiking
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: individuals hiking The Colorado Trail in its entirety in summer 2024. Excluded are those having hiked another thru-hike 6 months prior.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- Thru-hiking
- Being tested
- Thru-hiking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thru-hikingOther
planning to embark on the Colorado Trail
| Study group | Role | What they receive |
|---|---|---|
| thru-hiking on the Colorado Trail | Thru-hikers planning to embark on the Colorado Trail are recruited through the Colorado Trail Foundation community page and email newsletter, ensuring a sample population representative of those undertaking this challenging endeavor.
Participants will be tracked over time to assess changes in their metabolic health and dietary habits. Receives: Other: Thru-hiking |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood lipid panel: total cholesterol
changes in total cholesterol levels from baseline to within 2 days of completing the Colorado Trail.
Measured: baseline and 2 days post-hike
blood lipid panel: high-density lipoprotein (HDL)
changes in HDL levels from baseline to within 2 days of completing the Colorado Trail.
Measured: baseline and 2 days post-hike
blood lipid panel: low-density lipoprotein (LDL)
changes in LDL levels from baseline to within 2 days of completing the Colorado Trail.
Measured: baseline and 2 days post-hike
blood lipid panel: triglycerides
changes in triglycerides levels from baseline to within 2 days of completing the Colorado Trail.
Measured: baseline and 2 days post-hike
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thru-hikingStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Selinsky, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358274
- Sponsor's protocol ID
- MED-2024-32848
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail
- ClinicalTrials.gov ID
- NCT06358274
- Acronym / sponsor ID
- MED-2024-32848
- Conditions
- Thru-hiking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thru-hiking on the Colorado Trail | – | Other: Thru-hikingThru-hikers planning to embark on the Colorado Trail are recruited through the Colorado Trail Foundation community page and email newsletter, ensuring a sample population representative of those undertaking this challenging endeavor. Participants will be tracked over time to assess changes in their metabolic health and dietary habits. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- individuals hiking The Colorado Trail in its entirety in summer 2024. Excluded are those having hiked another thru-hike 6 months prior.
Key inclusion criteria (8 listed)
- Thru-Hikers on the Colorado Trail:
- Individuals planning to commence their thru-hiking journey on the Colorado Trail in early July.
- Participants must reside in northern Colorado.
- Thru-Hiking History
- Participants must not have completed another thru-hike in the past 6 months.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thru-hikingplanning to embark on the Colorado Trail | Other | thru-hiking on the Colorado Trail |
Primary outcome
blood lipid panel: total cholesterol
Time frame: baseline and 2 days post-hike
changes in total cholesterol levels from baseline to within 2 days of completing the Colorado Trail.
blood lipid panel: high-density lipoprotein (HDL)
Time frame: baseline and 2 days post-hike
changes in HDL levels from baseline to within 2 days of completing the Colorado Trail.
blood lipid panel: low-density lipoprotein (LDL)
Time frame: baseline and 2 days post-hike
changes in LDL levels from baseline to within 2 days of completing the Colorado Trail.
blood lipid panel: triglycerides
Time frame: baseline and 2 days post-hike
changes in triglycerides levels from baseline to within 2 days of completing the Colorado Trail.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Selinsky, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thru-hiking, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood lipid panel: total cholesterol (time frame: baseline and 2 days post-hike). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.