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Completed

NCT Number: NCT05816551

Aging and Gastrointestinal Barrier Function

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermia Trial

Other

Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.

Control Trial

Other

Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.

Primary outcomes

  1. Log Lactulose/Rhamnose Following Control Trial

    Time frame: "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.

  2. Log Lactulose/Rhamnose Following Hyperthermia Trial

    Time frame: "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.

  3. Log Sucrose Following Control Trial

    Time frame: "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.

  4. Log Sucrose Following Hyperthermia Trial

    Time frame: "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 outcomes

  1. Change in Core Temperature During Hyperthermia Trial

    Time frame: "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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Impact of Aging on Gastrointestinal Barrier Function During Hyperthermia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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