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The primary objectives of the study are outlined below:
The proposed trial will be a randomized, 4 arm, placebo controlled, within-subject crossover, study design. It is a pilot trial to establish methods and collect the preliminary data (N=6). Subjects meeting eligibility criteria (see eligibility criteria) will participate in 4 study visits where they will receive one serving (equivalent to 100 kcal) of 1 of 4 treatments: watermelon rind, watermelon flesh, watermelon seeds or placebo.
Qualified subjects from the screening visit will be randomized into the study and provided with a standard breakfast consisting of a high carbohydrate and moderate fat western-type meal 3 hours after the treatment. Each subject will be asked to come for one screening visit, a pre-study visit, and four dinner pick-ups on the day before each of the four test visits. The study day visit will last for approximately 9 h with a follow up visit the next day (24 h) for blood collection to allow for the characterization of target watermelon polyphenols and metabolites in plasma. Subjects will be instructed not to alter their usual diet or fluid intake during the study periods. Seven days prior to each study day visit, subjects will be advised not to consume fruits and vegetables rich in polyphenols and carotenoids or other high phytochemical foods (watermelon and products, arugula, spinach, tea, berries, grapes, carrots, tomatoes, sweet potatoes etc.).
Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 3, 4, 5, 6, 7, 8 h and 24 hour (h). An assigned test treatment will be provided immediately after the 0 h blood collection, a breakfast meal will be provided immediately after the 2 h blood collection, and lunch after 6 h blood collection. FMD will be measured at 0 (fasting), 1, 3, 5, and 7h.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active1 | Active Comparator | watermelon rind |
|
| Active2 | Active Comparator | watermelon flesh |
|
| Active3 | Active Comparator | watermelon seeds |
|
| Control Comparator | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Watermelon Rind | Dietary Supplement | watermelon rind |
| |
| Watermelon Flesh |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative characterization of watermelon polyphenolic compounds in plasma over 24-hour in humans | This will be conducted by using ultra-high performance liquid chromatography iFunnel quadrupole time of flight mass spectrometer (UHPLC-QTOF-MS) and triple quadrupole mass spectrometer (UHPLC-QQQ-MS). | 24-hour Postprandial period |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in endothelial function using ultrasound technique after consumption of each treatment | Flow Mediated Vasodilation imaging of the brachial artery to assess endothelial-dependent relaxation | 24-hour Postprandial period |
| the relationship between plasma metabolites and FMD responses after consumption of treatments |
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Inclusion Criteria:
• Men or women, 20-45 years of age with body mass index (BMI) in range from 27.5-32 kg/m2
Exclusion Criteria:
• Men and women who smoke
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| Name | Affiliation | Role |
|---|---|---|
| Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
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| Dietary Supplement |
watermelon flesh |
|
| Watermelon Seeds | Dietary Supplement | watermelon seeds |
|
| Placebo | Dietary Supplement | Control Comparator |
|
Correlation between plasma metabolites and FMD Change |
| 24-hour Postprandial period |