Trial Outcomes & Findings for Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation (NCT NCT03889158)
NCT ID: NCT03889158
Last Updated: 2021-11-12
Results Overview
Flow-mediated dilation - Brachial artery vasodilator function will be noninvasively measured through assessment of brachial artery dilation using ultrasonography. The brachial artery will be imaged proximal to placement of a blood pressure cuff just below the antecubital fossa. Endothelium-dependent dilation of the brachial artery will be measured at baseline and again for 5 minutes following ischemic stimulus (inflation of a blood pressure cuff around the forearm to 250 mmHg for 5 minutes).
TERMINATED
PHASE4
35 participants
Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]
2021-11-12
Participant Flow
Due to the impact of COVID-19 on study recruitment, we have insufficient data to break the older adults into fit and unfit groups. These groups were thus combined into a single "Older Adults" Group.
Participant milestones
| Measure |
Older Adults
Individuals 55-75 years of age.
|
Younger Adults
Individuals 18-35 years of age
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
15
|
|
Overall Study
COMPLETED
|
16
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation
Baseline characteristics by cohort
| Measure |
Older Adults
n=16 Participants
Individuals 55-75 years of age
|
Younger Adults
n=9 Participants
Individuals 18-35 years of age
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 5 • n=5 Participants
|
24 years
STANDARD_DEVIATION 4 • n=7 Participants
|
50 years
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
16 participants
n=5 Participants
|
9 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Flow-mediated dilation
|
3.5 % change in diameter
STANDARD_DEVIATION 1.9 • n=5 Participants
|
6.3 % change in diameter
STANDARD_DEVIATION 3.3 • n=7 Participants
|
4.5 % change in diameter
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Pulse wave velocity
|
8.8 m/s
STANDARD_DEVIATION 2.1 • n=5 Participants
|
5.6 m/s
STANDARD_DEVIATION .4 • n=7 Participants
|
7.7 m/s
STANDARD_DEVIATION 2.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]Flow-mediated dilation - Brachial artery vasodilator function will be noninvasively measured through assessment of brachial artery dilation using ultrasonography. The brachial artery will be imaged proximal to placement of a blood pressure cuff just below the antecubital fossa. Endothelium-dependent dilation of the brachial artery will be measured at baseline and again for 5 minutes following ischemic stimulus (inflation of a blood pressure cuff around the forearm to 250 mmHg for 5 minutes).
Outcome measures
| Measure |
Older Adults
n=16 Participants
Individuals 55-75 years of age
|
Younger Adults
n=9 Participants
Individuals 18-35 years of age
|
|---|---|---|
|
Change in Endothelial Function
Baseline
|
2.4 % change in diameter
Standard Deviation 1.8
|
5.5 % change in diameter
Standard Deviation 3.4
|
|
Change in Endothelial Function
Baseline + Vit C
|
3.4 % change in diameter
Standard Deviation 2.7
|
5.7 % change in diameter
Standard Deviation 3.0
|
|
Change in Endothelial Function
Pre-Inflammation Baseline
|
3.4 % change in diameter
Standard Deviation 1.9
|
6.3 % change in diameter
Standard Deviation 3.3
|
|
Change in Endothelial Function
Inflammation
|
1.6 % change in diameter
Standard Deviation 1.7
|
5.8 % change in diameter
Standard Deviation 3.4
|
|
Change in Endothelial Function
Inflammation + Vit C
|
2.8 % change in diameter
Standard Deviation 1.9
|
6.1 % change in diameter
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]Oxidized low-density lipoprotein, vitamin C and total antioxidant capacity will be assessed using standard ELISAs from a venous blood draw. The analyses of the oxidized LDL and total antioxidant capacity failed. Only data on Vitamin C are presented.
Outcome measures
| Measure |
Older Adults
n=16 Participants
Individuals 55-75 years of age
|
Younger Adults
n=9 Participants
Individuals 18-35 years of age
|
|---|---|---|
|
Change in Oxidative Stress
Baseline
|
6.2 ug/mL
Standard Deviation 1.2
|
4.7 ug/mL
Standard Deviation 2.1
|
|
Change in Oxidative Stress
Baseline + Vit C
|
13.3 ug/mL
Standard Deviation 2.1
|
11.7 ug/mL
Standard Deviation 2.9
|
|
Change in Oxidative Stress
Pre-Inflammation
|
5.8 ug/mL
Standard Deviation 1.1
|
5.4 ug/mL
Standard Deviation 1.2
|
|
Change in Oxidative Stress
Inflammation
|
6.6 ug/mL
Standard Deviation 1.1
|
7.2 ug/mL
Standard Deviation 4.1
|
|
Change in Oxidative Stress
Inflammation + Vit C
|
13.4 ug/mL
Standard Deviation 3.1
|
13.3 ug/mL
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]Central pulse wave velocity - Approximately 20-sec of pressure waveforms will be collected at the brachial, common carotid, and femoral arteries using a high-fidelity strain-gauge transducer. Pulse wave velocity will be calculated from the distances between measurement points and the measured time delay between proximal (carotid) and distal (femoral) waveforms.
Outcome measures
| Measure |
Older Adults
n=16 Participants
Individuals 55-75 years of age
|
Younger Adults
n=9 Participants
Individuals 18-35 years of age
|
|---|---|---|
|
Change in Arterial Stiffness
Baseline
|
9.3 m/s
Standard Deviation 2.0
|
5.8 m/s
Standard Deviation .8
|
|
Change in Arterial Stiffness
Baseline + Vit C
|
9.9 m/s
Standard Deviation 3.0
|
5.9 m/s
Standard Deviation .9
|
|
Change in Arterial Stiffness
Pre-inflammation
|
8.8 m/s
Standard Deviation 2.1
|
5.6 m/s
Standard Deviation .4
|
|
Change in Arterial Stiffness
Inflammation
|
8.8 m/s
Standard Deviation 1.7
|
5.6 m/s
Standard Deviation .6
|
|
Change in Arterial Stiffness
Inflammation + Vit C
|
8.9 m/s
Standard Deviation 2.1
|
5.7 m/s
Standard Deviation .5
|
Adverse Events
Older Adults
Younger Adults
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elizabeth Lefferts
University of Illinois at Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place