An interventional study of Watermelon Flesh Dose 1 and Watermelon Flesh Dose 2 in Pre-hypertension and Cardiovascular Diseases, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Prevention
The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening.
The proposed study is a randomized, three-arm (n=12/arm), single-blinded, placebo-controlled, 4-week, parallel study design in individuals with pre-hypertension (systolic BP ≥ 120-139 mm Hg or a diastolic BP ≥ 80-89 mm Hg).
Pre-Screening: To learn more about the study and to pre-qualify, potential subjects can call the Clinical Nutrition Research Center (CNRC) or visit the website posted on recruitment flyers or from other recruitment materials. If individuals call the CNRC, a staff member will provide a brief background on the study and ask a series of questions from a pre-screening questionnaire to assess eligibility. The same questionnaire is available on the website and can be filled out by potential subjects online. The pre-screening questionnaire includes self-reported information about health status and lifestyle factors that can be used to determine if someone is not eligible for the study.
Screening: Participants will be asked to read, ask questions, sign and date the Institutional Review Board (IRB) approved Informed Consent Form (ICF) before any laboratory or study screening procedures begin. Participants will be informed of study procedures and schedules. Once ICF is signed by participant and staff, height, weight and waist circumference measurements, vital signs measurements, body temperature measurements (by contactless thermometer), and a finger prick (to confirm fasting status and blood sugar) will be collected.
Pre-Study Visit: If participants are eligible and willing to continue, a pre-study visit will be scheduled. The pre-study visit is for training on various aspects of the study. Participants will have diet counseling on foods that are rich in the components typically found in watermelon (e.g. tomatoes, carrots, sweet potatoes, etc.). Participants will be asked to avoid these foods for at least 7 days before the first study visit day. There will also be coaching on how to complete a 3-day food record that will be collected at each study visit.
At the Pre-Study Visit study participants will be randomized equally to each test group (n=12/group) according to a computer-generated randomization sequence. Participants will receive one of the three study test beverages:
Study Visit Days: There will be 3 study days that will take approximately 1-1.5 hours. Study visit days will occur on day 0, 14, and 30. Before each study visit participants will be asked to consume a fixed dinner the night before at least 10 hours prior to the visit. A 3-day food record will be collected at the visit.
Measurements include height, weight, waist circumferences, blood pressure, body temperature, heart rate, and fasting blood glucose. A fasting urine and blood sample will then be collected.
Participants will consume the first study test beverage (Control, WF1 or WF2) on-site and will be given test beverages to take home and instructed to consume the beverage every day in the morning between 8-10 am for 4 weeks. Treatment beverages will be given to the participant to consume over the next 2 weeks at day 14 (visit 3). 24-hour Ambulatory Blood Pressure Machine (ABPM) will be distributed after consuming the test beverages on day 0 and day 28 during the visit.
Follow up visits: 24-hours after visit 1 and 4, ABPM machines will be returned. Treatment beverages will be given to the participant to consume over the next 2 weeks at the first follow up visit.
158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.
This study's enrollment of 39 is below the median of 66 across 138 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Clinical Nutrition Research Center, Illinois Institute of Technology is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Calorie-matched control beverage
Other: Control
1 cup watermelon flesh, \~152 g
Other: Watermelon Flesh Dose 1
2 cups watermelon flesh, \~304 g
Other: Watermelon Flesh Dose 2
1 cup watermelon flesh, \~152g, 7 days/week over a 4-week period
2 cups watermelon flesh, \~304 g, 7 days/week over a 4-week period
304g italian ice, 0 g watermelon, 7 days/week over a 4-week period
To evaluate the change in the dose response effects of watermelon flesh in regulating BP in individuals with pre-hypertension.
This objective will be accomplished by assessing the 24-h Ambulatory Blood Pressure Machine (ABPM) in individuals with pre-hypertension before and after 4 weeks of watermelon flesh intake. Two doses of watermelon flesh will be tested (1 and 2 cup servings) compared to control.
Time frame: Baseline to 4 weeks
To evaluate the change in lipid profile in individuals with pre-hypertension after consuming watermelon flesh.
Randox automated clinical analyzer measuring total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Time frame: Baseline to 4 weeks
To evaluate the change in plasma and urine nitrite/nitrate in individuals with pre-hypertension after consuming watermelon flesh.
Plasma and urine nitrate ad nitrite concentrations will be measured using Griess assay
Time frame: Baseline to 4 weeks
To evaluate the change in glucose in individuals with pre-hypertension after consuming watermelon flesh.
Randox automated clinical analyzer measuring glucose
Time frame: Baseline to 4 weeks
To evaluate the change in insulin in individuals with pre-hypertension after consuming watermelon flesh.
Randox automated clinical analyzer measuring glucose
Time frame: Baseline to 4 weeks
To evaluate the changes in L-Citrulline, Arginine, and Asymmetric Dimethylarginine (ADMA) in individuals with pre-hypertension after consuming watermelon flesh, analyzed by mass spectrometry.
Collected plasma samples will be extracted with 0.1% formic acid in isopropanol. The samples will be centrifuged, filtered and analyzed for L-citrulline, arginine and ADMA on ultra-high performance liquid chromatography triple quadrupole mass spectrometry (UHPLC-QQQ-MS)
Time frame: Baseline to 4 weeks
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clinical Nutrition Research Center, Illinois Institute of Technology →