Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in Elders: The MOXIE Study
Phase: NA
Conditions: Arterial Stiffness, Inflammation
Sponsor: University of Alabama, Tuscaloosa

 
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Bioactive Compounds in Watermelon Modulating Oxidative Stress and Inflammation in  
Elders 
 
 
NCT03626168 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
February 16, 2016 
 
 

 
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Protocol 
 
Study participants will be randomized to supplement their diets twice daily with either 100% 
watermelon juice or an isocaloric placebo for four weeks in a double-blind crossover design.  
Juice and placebo will be provided in two 12-ounce servings, and participants will be asked to 
consume one dose in the morning and another in the evening with a meal containing dietary 
lipid. Based on previous studies 62,87, two 12-ounce servings of 100% watermelon juice will 
provide approximately 1g of L-citrulline and 32 mg of lycopene. Pasteurized watermelon juice 
for this study will be supplied by Frey Farms (Keenes, IL) from Estrella variety melons. To 
ensure that all juice contains similar concentrations of the bioactive food compounds of 
interest, each batch will be tested in the Food and Nutrition Research Laboratory at the 
University of Alabama for lycopene, citrulline, and arginine content.  
Two weeks prior to the intervention, during each intervention arm, and during the washout 
period, subjects will be asked to consume their typical diet of choice with the exception of 
foods high in lycopene.  A list of lycopene-rich foods such as watermelon and tomato products 
will be provided, and participants will be asked to limit these foods to two servings per day for 
the duration of the study.  Dietary intake will be closely monitored by 4-day food diaries (three 
weekdays, one weekend day) submitted during the 2-week run-in period and the 2-week 
washout period as well as by weekly unannounced 24-hour diet recalls during the treatment 
period. 
 
Subjects will report to the University of Alabama campus for testing as follows:  
Run-In 
4-Week Regimen 
of Juice or Placebo 
2-Week 
Washout 
4-Week Regimen 
of Juice or Placebo 
Days 
0-14 
Beginning of 
Week 1 
End of Week 4 
Weeks 
5 & 6 
Beginning of 
Week 7 
End of Week 
10 
4-day 
food 
diary 
Fasting blood 
sample 
Fasting blood 
sample 
4-day 
food 
diary 
Fasting blood 
sample 
Fasting blood 
sample 
 
Anthropometrics 
Anthropometrics 
 
Anthropometrics 
Anthropometrics 
 
FMD 
FMD 
 
FMD 
FMD 
 
PWV 
PWV 
 
PWV 
PWV 
Weekly: Weight, Blood Pressure, Adherence 
During weekly visits and phone calls with study personnel, subjects will be queried about 
adherence to the protocol and acceptability of the beverages.  Adherence will be assessed by 
log forms with check-off boxes for each dose, return of all juice bottles at weekly visits, and 
random 24-hour diet recalls.  Minimal adherence will be defined as 70% of recommended 
supplementation of two doses per day for four weeks. 
Statistical Analysis 
A biostatistician from the University of Alabama will be responsible for generating a block 
randomization with PROC PLAN in SAS (version 9.2). The randomization scheme will balance 
genotype in Groups 2 and 3 (those who receive genetic information at the beginning of the 
intervention). Differences between groups will be evaluated by one-way ANOVA with repeated 
measures with group as the between-subjects factor and time as the within-subjects factor.