Trial Outcomes & Findings for Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders (NCT NCT03626168)
NCT ID: NCT03626168
Last Updated: 2022-05-17
Results Overview
Lycopene determined by ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline and 4 Weeks
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
100% Watermelon Juice First, Then Placebo Beverage
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
2-week washout period
Consumption of two 12-ounce doses of placebo beverage for a four-week period
|
Placebo Beverage First, Then 100% Watermelon Juice
Consumption of two 12-ounce doses of placebo beverage for a four-week period
2-week washout period
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
|
|---|---|---|
|
First Intervention (4 Weeks)
STARTED
|
9
|
12
|
|
First Intervention (4 Weeks)
COMPLETED
|
8
|
11
|
|
First Intervention (4 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Washout (2 Weeks)
STARTED
|
8
|
11
|
|
Washout (2 Weeks)
COMPLETED
|
8
|
11
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 Weeks)
STARTED
|
8
|
11
|
|
Second Intervention (4 Weeks)
COMPLETED
|
8
|
9
|
|
Second Intervention (4 Weeks)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
100% Watermelon Juice First, Then Placebo Beverage
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
2-week washout period
Consumption of two 12-ounce doses of placebo beverage for a four-week period
|
Placebo Beverage First, Then 100% Watermelon Juice
Consumption of two 12-ounce doses of placebo beverage for a four-week period
2-week washout period
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
|
|---|---|---|
|
First Intervention (4 Weeks)
Withdrawal by Subject
|
1
|
0
|
|
First Intervention (4 Weeks)
Began a medication that precluded participation
|
0
|
1
|
|
Second Intervention (4 Weeks)
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders
Baseline characteristics by cohort
| Measure |
100% Watermelon Juice First, Then Placebo Beverage
n=9 Participants
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
2-week washout period
Consumption of two 12-ounce doses of placebo beverage for a four-week period
|
Placebo Beverage First, Then 100% Watermelon Juice
n=11 Participants
Consumption of two 12-ounce doses of placebo beverage for a four-week period
2-week washout period
Consumption of two 12-ounce doses of 100% watermelon juice for a four-week period
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.78 years
STANDARD_DEVIATION 4.99 • n=99 Participants
|
58.91 years
STANDARD_DEVIATION 2.91 • n=107 Participants
|
60.20 years
STANDARD_DEVIATION 4.14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
11 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Weight
|
59.69 kg
STANDARD_DEVIATION 10.07 • n=99 Participants
|
69.96 kg
STANDARD_DEVIATION 5.75 • n=107 Participants
|
65.34 kg
STANDARD_DEVIATION 9.36 • n=206 Participants
|
|
Body mass index (BMI)
|
22.61 kg/m^2
STANDARD_DEVIATION 3.21 • n=99 Participants
|
27.12 kg/m^2
STANDARD_DEVIATION 2.51 • n=107 Participants
|
25.08 kg/m^2
STANDARD_DEVIATION 3.60 • n=206 Participants
|
|
Serum lycopene
|
1.55 uM
STANDARD_DEVIATION 0.70 • n=99 Participants
|
1.26 uM
STANDARD_DEVIATION 0.87 • n=107 Participants
|
1.37 uM
STANDARD_DEVIATION 0.80 • n=206 Participants
|
|
Serum arginine
|
65.51 uM
STANDARD_DEVIATION 24.54 • n=99 Participants
|
54.64 uM
STANDARD_DEVIATION 16.10 • n=107 Participants
|
58.87 uM
STANDARD_DEVIATION 19.87 • n=206 Participants
|
|
Serum citrulline
|
30.43 uM
STANDARD_DEVIATION 6.82 • n=99 Participants
|
24.23 uM
STANDARD_DEVIATION 6.16 • n=107 Participants
|
26.64 uM
STANDARD_DEVIATION 6.96 • n=206 Participants
|
|
Oxygen radical absorbance capacity (ORAC)
|
642.05 uM Trolox Equivalents
STANDARD_DEVIATION 196.40 • n=99 Participants
|
827.67 uM Trolox Equivalents
STANDARD_DEVIATION 231.07 • n=107 Participants
|
749.51 uM Trolox Equivalents
STANDARD_DEVIATION 231.36 • n=206 Participants
|
|
TNF-alpha
|
2.32 pg/ml
STANDARD_DEVIATION 0.37 • n=99 Participants
|
2.52 pg/ml
STANDARD_DEVIATION 0.56 • n=107 Participants
|
2.44 pg/ml
STANDARD_DEVIATION 0.50 • n=206 Participants
|
|
Oxidized LDL
|
75.10 uM/dl
STANDARD_DEVIATION 12.10 • n=99 Participants
|
75.61 uM/dl
STANDARD_DEVIATION 9.93 • n=107 Participants
|
75.41 uM/dl
STANDARD_DEVIATION 10.48 • n=206 Participants
|
|
Flow-mediated dilation (FMD)
|
10.17 percentage of change in diameter
STANDARD_DEVIATION 7.44 • n=99 Participants
|
7.93 percentage of change in diameter
STANDARD_DEVIATION 6.04 • n=107 Participants
|
8.94 percentage of change in diameter
STANDARD_DEVIATION 6.62 • n=206 Participants
|
|
Pulse wave velocity (PWV)
|
8.40 meters per second
STANDARD_DEVIATION 0.75 • n=99 Participants
|
8.20 meters per second
STANDARD_DEVIATION 0.69 • n=107 Participants
|
8.29 meters per second
STANDARD_DEVIATION 0.71 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 WeeksPopulation: Serum lycopene was unavailable for one participant due to an insufficient blood sample. With the crossover design, participants completed both arms of the study with a two-week washout period in between.
Lycopene determined by ultra high performance liquid chromatography with photodiode array detector (UPLC-PDA).
Outcome measures
| Measure |
Consumption of 100% Watermelon Juice
n=16 Participants
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
100% watermelon juice: Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period.
|
Consumption of a Placebo Beverage
n=16 Participants
Consumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period
Placebo beverage: Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period.
|
|---|---|---|
|
Change From Baseline in Serum Levels of Lycopene at 4 Weeks
|
7.30 uM
Standard Deviation 7.55
|
3.09 uM
Standard Deviation 4.92
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: With the crossover design, participants completed both arms of the study with a two-week washout period in between.
Determined by brachial artery flow-mediated dilation (FMD). 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.
Outcome measures
| Measure |
Consumption of 100% Watermelon Juice
n=17 Participants
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
100% watermelon juice: Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period.
|
Consumption of a Placebo Beverage
n=17 Participants
Consumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period
Placebo beverage: Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period.
|
|---|---|---|
|
Change in Vascular Endothelial Function at 4 Weeks
|
2.85 percentage of change in diameter
Standard Deviation 7.81
|
2.17 percentage of change in diameter
Standard Deviation 9.25
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: With the crossover design, participants completed both arms of the study with a two-week washout period in between.
Determined by pulse wave velocity (PWV). A cuff-based system was used to measure brachial oscillometric pressure waveforms and generate central pressure curves by propriety algorithms. PWV was quantified as the rate at which a pulse wave moves down a vessel.
Outcome measures
| Measure |
Consumption of 100% Watermelon Juice
n=17 Participants
Consumption of two 12-ounce doses of pasteurized 100% watermelon juice for a four-week period
100% watermelon juice: Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period.
|
Consumption of a Placebo Beverage
n=17 Participants
Consumption of a placebo beverage with comparable sugar content, pH, taste, texture, and color for a four-week period
Placebo beverage: Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period.
|
|---|---|---|
|
Change in Arterial Stiffness at 4 Weeks
|
-0.029 meters/second
Standard Deviation 0.269
|
-0.188 meters/second
Standard Deviation 0.486
|
Adverse Events
Consumption of 100% Watermelon Juice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Consumption of a Placebo Beverage
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
Dr. Amy Ellis, principal investigator
The University of Alabama
Phone: 205-348-8128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place