Trial Outcomes & Findings for Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes (NCT NCT04633551)

NCT ID: NCT04633551

Last Updated: 2023-09-21

Results Overview

Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2023-09-21

Participant Flow

Participant milestones

Measure	Intervention Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Overall Study STARTED	6	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We did not perform blood draws successfully on all participants.

Baseline characteristics by cohort

Measure	Intervention n=5 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control n=3 Participants Participants in this arm will not receive a commercially available anti-inflammatory supplement.	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=3 Participants	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Age, Continuous	33 years STANDARD_DEVIATION 6 • n=5 Participants	30 years STANDARD_DEVIATION 6 • n=3 Participants	32 years STANDARD_DEVIATION 6 • n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=3 Participants	8 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=3 Participants	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=3 Participants	4 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=3 Participants	3 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=3 Participants	8 participants n=8 Participants
Systolic Blood Pressure	118 mmHg STANDARD_DEVIATION 22 • n=5 Participants	119 mmHg STANDARD_DEVIATION 15 • n=3 Participants	118 mmHg STANDARD_DEVIATION 18 • n=8 Participants
Arterial stiffness	6.4 m/s STANDARD_DEVIATION 0.5 • n=5 Participants	8.3 m/s STANDARD_DEVIATION 2.7 • n=3 Participants	7.3 m/s STANDARD_DEVIATION 1.9 • n=8 Participants
Augmentation index	24 percentage STANDARD_DEVIATION 6 • n=5 Participants	25 percentage STANDARD_DEVIATION 5 • n=3 Participants	24 percentage STANDARD_DEVIATION 5 • n=8 Participants
Central systolic blood pressure	108 mmHg STANDARD_DEVIATION 15 • n=5 Participants	110 mmHg STANDARD_DEVIATION 13 • n=3 Participants	109 mmHg STANDARD_DEVIATION 14 • n=8 Participants
Reactive hyperemia	7.7 ml/100 mg tissue/min STANDARD_DEVIATION 3.3 • n=5 Participants	13.2 ml/100 mg tissue/min STANDARD_DEVIATION 12.5 • n=3 Participants	9.7 ml/100 mg tissue/min STANDARD_DEVIATION 7.7 • n=8 Participants
Inflammatory biomarker IL-6	NA pg/dl STANDARD_DEVIATION NA • n=4 Participants • We did not perform blood draws successfully on all participants.	NA pg/dl STANDARD_DEVIATION NA • n=1 Participants • We did not perform blood draws successfully on all participants.	NA pg/dl STANDARD_DEVIATION NA • n=5 Participants • We did not perform blood draws successfully on all participants.

PRIMARY outcome

Timeframe: 1 month

Population: Participants who completed Visit 2.

Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure

Outcome measures

Measure	Intervention n=5 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control n=3 Participants Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Blood Pressure (mmHg)	122 mmHg Standard Error 9	116 mmHg Standard Error 9

PRIMARY outcome

Timeframe: 1 month

Population: Only participants who completed Visit 2.

Arterial stiffness will be measured with pulse wave velocity using applanation tonometry and heart rate

Outcome measures

Measure	Intervention n=5 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control n=3 Participants Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Arterial Stiffness (m/s)	6.2 m/s Standard Error 0.7	7.8 m/s Standard Error 1.2

PRIMARY outcome

Timeframe: 1 month

Applanation tonometry will be used to describe systolic blood pressure augmentation, a measure of arterial wave reflection intensity.

Outcome measures

Measure	Intervention n=5 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control n=3 Participants Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Augmentation Index (%)	23 percentage Standard Error 3	22 percentage Standard Error 4

PRIMARY outcome

Timeframe: 1 month

Venous occlusion plethysmography will be used to mease the change in forearm blood flow after a 5-min occlusion

Outcome measures

Measure	Intervention n=5 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control n=3 Participants Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Endothelial Function (Reactive Hyperemia)	6.6 ml/100 mg tissue/min Standard Error 3.4	7.6 ml/100 mg tissue/min Standard Error 5.6

SECONDARY outcome

Timeframe: 1 month

Population: Unable to perform blood draws on all participants.

concentrations of circulating adhesion molecules ICAM and VCAM

Outcome measures

Measure	Intervention n=4 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control n=1 Participants Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Inflammatory Vascular Biomarkers (pg/dL)	NA pg/dl Standard Deviation NA Undetected values	NA pg/dl Standard Deviation NA Undetected values

SECONDARY outcome

Timeframe: 1 month

Surveys regarding opinion and likelihood of taking supplements. Here we report the number of participants who thought supplements were somewhat or extremely useful (Likert score of 4-5) for improving health.

Outcome measures

Measure	Intervention n=6 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control n=3 Participants Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields)	6 Participants	3 Participants

SECONDARY outcome

Timeframe: 1 month

Population: Only Intervention group participants who completed Visit 2 were included.

Interviews will be used to determine barriers and facilitators of adherence. We report number of participants who were happy with contact with study team for adherence reminders.

Outcome measures

Measure	Intervention n=5 Participants Participants in this arm will receive a commercially available anti-inflammatory supplement. Anti-inflammatory supplement: commercially available combination of curcumin, quercitin, resveratrol, and green tea	Control Participants in this arm will not receive a commercially available anti-inflammatory supplement.
Perception of Intervention (15-20 Minute Interview)	5 Participants	—

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Abbi Lane-Cordova

University of South Carolina

Phone: 8037777568

Email: lanecord@mailbox.sc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place