- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06358274
Nutritional and Metabolic Dynamics of Thru-Hiking: A Longitudinal Study on the Colorado Trail
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 Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
planning to embark on the Colorado Trail
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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baseline and 2 days post-hike
|
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blood lipid panel: high-density lipoprotein (HDL)
Time Frame: baseline and 2 days post-hike
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changes in HDL levels from baseline to within 2 days of completing the Colorado Trail.
|
baseline and 2 days post-hike
|
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blood lipid panel: low-density lipoprotein (LDL)
Time Frame: baseline and 2 days post-hike
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changes in LDL levels from baseline to within 2 days of completing the Colorado Trail.
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baseline and 2 days post-hike
|
|
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.
|
baseline and 2 days post-hike
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen Selinsky, MD, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MED-2024-32848
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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