Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
Study NCT ID:
NCT05892328
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2023-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Watermelon Dose Response Blood Pressure Study
Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Organization:
Study Overview
Official Title:
Dose Response Effect of Watermelon Consumption on Ambulatory Blood Pressure in Adults With Pre-hypertension: A Randomized Controlled Pilot Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WMBP
Brief Summary:
1. Primary outcome: To evaluate the dose response effects of watermelon flesh in regulating Blood Pressure (BP) in individuals with pre-hypertension.
2. Secondary outcomes: To study the dose-response effects of watermelon flesh intake on cardio-metabolic risk factors including plasma metabolic markers, lipid profile and nitrate/nitrite levels in individuals with pre-hypertension.
2. Secondary outcomes: To study the dose-response effects of watermelon flesh intake on cardio-metabolic risk factors including plasma metabolic markers, lipid profile and nitrate/nitrite levels in individuals with pre-hypertension.
Detailed Description:
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:
1. Control (0 g watermelon),
2. Watermelon flesh Dose 1 (WF1, 1 cup watermelon flesh, \~152 g) or
3. Watermelon flesh Dose 2 (WF2, 2 cups watermelon flesh, \~304 g);
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.
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:
1. Control (0 g watermelon),
2. Watermelon flesh Dose 1 (WF1, 1 cup watermelon flesh, \~152 g) or
3. Watermelon flesh Dose 2 (WF2, 2 cups watermelon flesh, \~304 g);
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: