Aging and Gastrointestinal Barrier Function
Impact of Aging on Gastrointestinal Barrier Function During Hyperthermia
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedResults Posted
Study results publicly available
January 22, 2025
CompletedJanuary 22, 2025
January 1, 2025
1.3 years
March 15, 2023
October 7, 2024
January 21, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Log Lactulose/Rhamnose Following Control Trial
In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.
"Visit 1": 3-5 hours after ingestion of multiple sugar drink.
Log Lactulose/Rhamnose Following Hyperthermia Trial
In vivo gastrointestinal permeability measured by quantities of orally ingested multi-sugar drink excreted in urine. The urinary recovery of each ingested sugar (lactulose, sucrose and rhamnose) was determined by multiplying the measured concentration of each sugar by the total volume of urine collected and dividing by the dose administered. Since lactulose is degraded in the colon, we used the ratio urine lactulose to rhamnose (L/R) to determine small intestinal barrier permeability.
"Visit 2": 3-5 hours after ingestion of multiple sugar drink.
Log Sucrose Following Control Trial
The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.
"Visit 1": 3-5 hours after ingestion of multiple sugar drink.
Log Sucrose Following Hyperthermia Trial
The urinary recovery of sucrose was determined by multiplying the measured concentration of sucrose by the total volume of urine collected and dividing by the dose administered. Sucrose is broken down rapidly in the duodenum, thus we used the urinary excretion of sucrose to assess and gastroduodenal permeability.
"Visit 2": 3-5 hours after ingestion of multiple sugar drink.
Secondary Outcomes (1)
Change in Core Temperature During Hyperthermia Trial
"Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial.
Study Arms (2)
Younger participants
EXPERIMENTALIndividuals aged 18-39 years.
Older participants
EXPERIMENTALIndividuals aged over 65 years.
Interventions
Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
Eligibility Criteria
You may qualify if:
- Healthy male and female individuals
- years or 65+ years of age
- Free of any underlying moderate to serious medical conditions
You may not qualify if:
- Known heart disease
- Any chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, inflammatory bowel disease, and uncontrolled hypercholestrolmia etc;
- Abnormality detected on routine screening suggestive of provocable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
- Current smokers, as well as individuals who regularly smoked within the past 3 years
- Subject with a body mass index ≥35 kg/m2
- Pregnant
- Use of immunosuppressant drugs within last 4 weeks prior to screening
- Use of antibiotics or antimicrobial medication in last month
- Any previous abdominal surgery
- Use of steroids in last 6 weeks
- Regular use of probiotics in last month
- Use of laxatives or anti-diarrhetic in last month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Craig Crandall, PhD, Primary Investigator
- Organization
- Institute for Exercise and Environmental Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Craig G Crandall, Ph.D.
University of Texas Southwestern Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 15, 2023
First Posted
April 18, 2023
Study Start
July 1, 2023
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
January 22, 2025
Results First Posted
January 22, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share