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Aging and Gastrointestinal Barrier Function

Not Applicable
Completed
Conditions
Aging
Hyperthermia
Interventions
Other: Controlled hyperthermia
Registration Number
NCT05816551
Lead Sponsor
University of Texas Southwestern Medical Center
Brief Summary

The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.

Detailed Description

Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. Although gastrointestinal barrier dysfunction is a primary cause of heat related illness, little is known about the effects of aging on gastrointestinal barrier function during hyperthermia. The central hypothesis of this work is that the elderly exhibit greater gastrointestinal barrier dysfunction during hyperthermia. Participants will complete a control trial where gastrointestinal permeability (without heating) will be assessed in young and older adults. In the experimental trial, controlled hyperthermia will be achieved using a water perfused, tube lined suit. Core body temperature will be raised to a maximum of 2 degrees Celsius above the baseline value, or an absolute temperature of 39.5 degrees Celsius. Core temperature will not be collected during the control trial. Comprehensive assessments of gastrointestinal barrier function and systemic inflammation will be assessed in young and older adults. The expected outcome of this work will re-shape our understanding of the consequences of aging on gastrointestinal barrier function during heat waves.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
Inclusion Criteria
  • Healthy male and female individuals
  • 18-35 years or 65+ years of age
  • Free of any underlying moderate to serious medical conditions
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Younger participantsControlled hyperthermiaIndividuals aged 18-39 years
Older participantsControlled hyperthermiaIndividuals aged over 65 years
Primary Outcome Measures
NameTimeMethod
Log Lactulose/Rhamnose Following Control Trial"Visit 1": 3-5 hours after ingestion of multiple sugar drink.

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.

Log Lactulose/Rhamnose Following Hyperthermia Trial"Visit 2": 3-5 hours after ingestion of multiple sugar drink.

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.

Log Sucrose Following Control Trial"Visit 1": 3-5 hours after ingestion of multiple sugar drink.

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.

Log Sucrose Following Hyperthermia Trial"Visit 2": 3-5 hours after ingestion of multiple sugar drink.

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.

Secondary Outcome Measures
NameTimeMethod
Change in Core Temperature During Hyperthermia Trial"Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial.

Core temperature was measured using an orally ingestible telemetric pill that was taken no less than 1 hour before the baseline period.

Trial Locations

Locations (1)

Texas Health Presbyterian Hospital Dallas

🇺🇸

Dallas, Texas, United States

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