Trial Outcomes & Findings for Acute Effects of Watermelon on Vascular Function and Serum Lycopene (NCT NCT03608254)
NCT ID: NCT03608254
Last Updated: 2022-03-14
Results Overview
On the testing day, participants reported to the clinic following a 10-hour overnight fast. Blood samples were obtained by standard venipuncture at baseline and two hours after ingestion of a 360 ml dose of 100% pasteurized watermelon juice in order to determine change in serum lycopene levels.
COMPLETED
11 participants
2 hours post-ingestion
2022-03-14
Participant Flow
Participant milestones
| Measure |
Watermelon Juice
All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Watermelon Juice
All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
|
|---|---|
|
Overall Study
Blood sampling was not completed for 2 participants.
|
2
|
|
Overall Study
One participant chose not to consume the entire 12-ounce dose of watermelon juice.
|
1
|
Baseline Characteristics
Acute Effects of Watermelon on Vascular Function and Serum Lycopene
Baseline characteristics by cohort
| Measure |
Watermelon Juice
n=11 Participants
All participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
65.73 years
STANDARD_DEVIATION 2.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
|
Serum lycopene
|
1.48 umol/L
STANDARD_DEVIATION 1.07 • n=5 Participants
|
|
Flow-mediated dilation (FMD)
|
9.93 percent change in diameter
STANDARD_DEVIATION 6.09 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-ingestionPopulation: Eleven participants provided consent for the cross-sectional study. Blood sampling was not possible for two participants, and one participant did not consume the entire 12-ounce dose of juice.
On the testing day, participants reported to the clinic following a 10-hour overnight fast. Blood samples were obtained by standard venipuncture at baseline and two hours after ingestion of a 360 ml dose of 100% pasteurized watermelon juice in order to determine change in serum lycopene levels.
Outcome measures
| Measure |
Watermelon Juice
n=8 Participants
Participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
|
|---|---|
|
Change From Baseline in Circulating Lycopene Levels
|
2.85 umol/L
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 2 hours post-ingestionPopulation: One participant did not consume the entire 12-ounce dose of juice.
Brachial artery flow-mediated dilation (FMD) was used to assess endothelial-dependent vasodilation. FMD uses ultrasound technology to quantify changes in brachial artery diameter in response to hyperemia. A blood pressure cuff was placed distal to the brachial artery of the right arm with the participant supine and rested. Pre-inflation diameter was recorded for one minute, and the cuff was inflated to 50 mmHg above resting SBP for five minutes. Then, images were recorded for 120 seconds after cuff deflation. Peak diameter was determined as an average of the five highest measurements over five seconds post-deflation. FMD was expressed as the percentage increase in peak diameter. FMD measurements were taken at baseline and 2 hours after ingestion of the 100% watermelon juice. The outcome measure reflects change in FMD from baseline to 2 hours post-ingestion.
Outcome measures
| Measure |
Watermelon Juice
n=10 Participants
Participants consumed 12 ounces of 100% watermelon juice. Blood samples were taken, and flow-mediated dilation was measured before consumption of the juice and two hours afterward.
|
|---|---|
|
Change From Baseline in Endothelial-dependent Vasodilation
|
2.33 percent change from baseline
Standard Deviation 7.33
|
Adverse Events
Watermelon Juice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place