Trial Outcomes & Findings for Aging and Gastrointestinal Barrier Function (NCT NCT05816551)
NCT ID: NCT05816551
Last Updated: 2025-01-22
Results Overview
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.
COMPLETED
NA
22 participants
"Visit 1": 3-5 hours after ingestion of multiple sugar drink.
2025-01-22
Participant Flow
Participant milestones
| Measure |
Younger Participants
Individuals aged 18-39 years
Hyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
|
Older Participants
Individuals aged over 65 years
Hyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
Control Trial
|
11
|
9
|
|
Overall Study
Hyperthermia Trial
|
12
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Younger Participants
Individuals aged 18-39 years
Hyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
|
Older Participants
Individuals aged over 65 years
Hyperthermia Trial Individuals will be exposed to a controlled hyperthermia trial during "Visit 2" of the protocol.
Control Trial Individuals will be exposed to a control trial (no hyperthermia) during "Visit 1" of the protocol.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Withdrawn by Primary Investigator
|
3
|
0
|
Baseline Characteristics
Aging and Gastrointestinal Barrier Function
Baseline characteristics by cohort
| Measure |
Younger Participants
n=9 Participants
Individuals aged 18-39 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Older Participants
n=9 Participants
Individuals aged over 65 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 3 • n=5 Participants
|
72 years
STANDARD_DEVIATION 3 • n=7 Participants
|
52 years
STANDARD_DEVIATION 21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: "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.
Outcome measures
| Measure |
Younger Participants
n=9 Participants
Individuals aged 18-39 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Older Participants
n=9 Participants
Individuals aged over 65 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
|---|---|---|
|
Log Lactulose/Rhamnose Following Control Trial
|
0.97 Ratio
Standard Deviation 0.39
|
0.79 Ratio
Standard Deviation 0.30
|
PRIMARY outcome
Timeframe: "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.
Outcome measures
| Measure |
Younger Participants
n=9 Participants
Individuals aged 18-39 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Older Participants
n=9 Participants
Individuals aged over 65 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
|---|---|---|
|
Log Lactulose/Rhamnose Following Hyperthermia Trial
|
1.22 Ratio
Standard Deviation 0.32
|
1.21 Ratio
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: "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.
Outcome measures
| Measure |
Younger Participants
n=9 Participants
Individuals aged 18-39 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Older Participants
n=9 Participants
Individuals aged over 65 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
|---|---|---|
|
Log Sucrose Following Control Trial
|
2.68 log(ng/mL)
Standard Deviation 1.11
|
1.74 log(ng/mL)
Standard Deviation 1.66
|
PRIMARY outcome
Timeframe: "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.
Outcome measures
| Measure |
Younger Participants
n=9 Participants
Individuals aged 18-39 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Older Participants
n=9 Participants
Individuals aged over 65 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
|---|---|---|
|
Log Sucrose Following Hyperthermia Trial
|
2.83 log(ng/mL)
Standard Deviation 1.10
|
3.44 log(ng/mL)
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: "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.
Outcome measures
| Measure |
Younger Participants
n=9 Participants
Individuals aged 18-39 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Older Participants
n=9 Participants
Individuals aged over 65 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
|---|---|---|
|
Change in Core Temperature During Hyperthermia Trial
|
2.01 °C
Standard Deviation .14
|
1.95 °C
Standard Deviation .23
|
Adverse Events
Younger Participants Hyperthermia Trial
Older Participants Hyperthermia Trial
Younger Participants Control Trial
Older Participants Control Trial
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Younger Participants Hyperthermia Trial
n=12 participants at risk
Individuals aged 18-39 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
|
Older Participants Hyperthermia Trial
n=9 participants at risk
Individuals aged over 65 years
Hyperthermia Trial: Individuals will be exposed to a controlled hyperthermia trial.
|
Younger Participants Control Trial
n=11 participants at risk
Individuals aged 18-39 years
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
Older Participants Control Trial
n=9 participants at risk
Individuals aged over 65 years
Control Trial: Individuals will be exposed to a control trial (no hyperthermia).
|
|---|---|---|---|---|
|
General disorders
Syncope
|
0.00%
0/12 • During the two trials of the experiment or approximately 2 weeks.
|
11.1%
1/9 • Number of events 1 • During the two trials of the experiment or approximately 2 weeks.
|
0.00%
0/11 • During the two trials of the experiment or approximately 2 weeks.
|
0.00%
0/9 • During the two trials of the experiment or approximately 2 weeks.
|
Additional Information
Craig Crandall, PhD, Primary Investigator
Institute for Exercise and Environmental Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place