Aging and Gastrointestinal Barrier Function

NCT ID: NCT05816551

Last Updated: 2025-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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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

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Aging Hyperthermia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Younger participants

Individuals aged 18-39 years.

Group Type EXPERIMENTAL

Hyperthermia Trial

Intervention Type OTHER

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

Control Trial

Intervention Type OTHER

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

Older participants

Individuals aged over 65 years.

Group Type EXPERIMENTAL

Hyperthermia Trial

Intervention Type OTHER

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

Control Trial

Intervention Type OTHER

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

Interventions

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Hyperthermia Trial

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

Intervention Type OTHER

Control Trial

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Craig Crandall

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig G Crandall, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Texas Health Presbyterian Hospital Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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STU-2023-0171

Identifier Type: -

Identifier Source: org_study_id

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