AgingNCT05816551
Aging and Gastrointestinal Barrier Function
A study testing Hyperthermia Trial in people with Aging and Hyperthermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Hyperthermia
- What is being tested?
- Hyperthermia Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female individuals
- 18-35 years or 65+ years of age
- Free of any underlying moderate to serious medical conditions
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
About this study
Official title: Impact of Aging on Gastrointestinal Barrier Function During Hyperthermia
The purpose of this study is to assess the gastrointestinal responses of the elderly and younger populations during hyperthermia.
Read the 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.
- Conditions
- Aging, Hyperthermia
- Being tested
- Hyperthermia Trial, Control Trial
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermia TrialOther
Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control TrialOther
Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Younger participants | Experimental | Individuals aged 18-39 years. Receives: Other: Hyperthermia Trial; Other: Control Trial |
| Older participants | Experimental | Individuals aged over 65 years. Receives: Other: Hyperthermia Trial; Other: Control Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "Visit 2": 3-5 hours after ingestion of multiple sugar drink.
Secondary outcomes (1)
Change in Core Temperature During Hyperthermia Trial
Core temperature was measured using an orally ingestible telemetric pill that was taken no less than 1 hour before the baseline period.
Measured: "Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jul 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
- Investigators
- Craig G Crandall, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816551
- Sponsor's protocol ID
- STU-2023-0171
- Status last verified
- Jan 2025
- First submitted
- 15 Mar 2023
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aging on Gastrointestinal Barrier Function During Hyperthermia
- ClinicalTrials.gov ID
- NCT05816551
- Acronym / sponsor ID
- STU-2023-0171
- Conditions
- Aging, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger participants | Experimental | Other: Hyperthermia Trial, Other: Control TrialIndividuals aged 18-39 years. |
| Older participants | Experimental | Other: Hyperthermia Trial, Other: Control TrialIndividuals aged over 65 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female individuals
- 18-35 years or 65+ years of age
- Free of any underlying moderate to serious medical conditions
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Hyperthermia TrialIndividuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol. | Other | Older participants, Younger participants |
| Control TrialIndividuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol. | Other | Older participants, Younger participants |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Change in Core Temperature During Hyperthermia Trial
Time frame: "Visit 2": At 0 minutes and 50-90minutes into the hyperthermia trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Craig G Crandall, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia Trial in people with Aging and Hyperthermia, run by University of Texas Southwestern Medical Center 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 3 inclusion and 12 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 22 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?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Log Lactulose/Rhamnose Following Control Trial (time frame: "Visit 1": 3-5 hours after ingestion of multiple sugar drink.). 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 22 Jan 2025.