The Effects of Watermelon Juice Supplementation on Postprandial Vascular Endothelial Function
WMJ
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to test if watermelon juice supplementation improves vascular dysfunction experience during hyperglycemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2019
CompletedFirst Submitted
Initial submission to the registry
September 15, 2019
CompletedFirst Posted
Study publicly available on registry
September 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2020
CompletedResults Posted
Study results publicly available
July 30, 2024
CompletedJuly 30, 2024
July 1, 2024
6 months
September 15, 2019
April 21, 2023
July 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Endothelial Function
Flow mediated dilation
Two weeks
Secondary Outcomes (1)
Postprandial Blood Flow
Two weeks
Study Arms (2)
Watermelon juice
EXPERIMENTALThe study participants consumed 500 ml of 100% watermelon juice for two weeks
Placebo
PLACEBO COMPARATORThe study participants consumed a watermelon flavored, fructose matched control
Interventions
Eligibility Criteria
You may not qualify if:
- years of age
- BMI between 18-29.9 kg/m2
- Willing to allow researchers to draw blood and conduct imaging (DXA) for research purposes.
- Evidence or self-reported history of type 1 or 2 diabetes mellitus
- Self-reported family history of type 2 diabetes (first degree relative with type 2 diabetes)
- Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
- Allergy to watermelon
- Use of medication known to influence study outcomes, such as:
- Insulin
- Anti-diabetics (metformin)
- Corticosteroids
- Beta-blockers
- Anti-coagulates
- Use of supplements known to influence study outcomes, such as;
- Beta-alanine
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Related Publications (13)
Baena-Diez JM, Penafiel J, Subirana I, Ramos R, Elosua R, Marin-Ibanez A, Guembe MJ, Rigo F, Tormo-Diaz MJ, Moreno-Iribas C, Cabre JJ, Segura A, Garcia-Lareo M, Gomez de la Camara A, Lapetra J, Quesada M, Marrugat J, Medrano MJ, Berjon J, Frontera G, Gavrila D, Barricarte A, Basora J, Garcia JM, Pavone NC, Lora-Pablos D, Mayoral E, Franch J, Mata M, Castell C, Frances A, Grau M; FRESCO Investigators. Risk of Cause-Specific Death in Individuals With Diabetes: A Competing Risks Analysis. Diabetes Care. 2016 Nov;39(11):1987-1995. doi: 10.2337/dc16-0614. Epub 2016 Aug 4.
PMID: 27493134BACKGROUNDBerrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, Moore SC, Tobias GS, Anton-Culver H, Freeman LB, Beeson WL, Clipp SL, English DR, Folsom AR, Freedman DM, Giles G, Hakansson N, Henderson KD, Hoffman-Bolton J, Hoppin JA, Koenig KL, Lee IM, Linet MS, Park Y, Pocobelli G, Schatzkin A, Sesso HD, Weiderpass E, Willcox BJ, Wolk A, Zeleniuch-Jacquotte A, Willett WC, Thun MJ. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010 Dec 2;363(23):2211-9. doi: 10.1056/NEJMoa1000367.
PMID: 21121834BACKGROUNDAvogaro A. Postprandial glucose: marker or risk factor? Diabetes Care. 2011 Oct;34(10):2333-5. doi: 10.2337/dc11-1442. No abstract available.
PMID: 21949226BACKGROUNDEnkhmaa B, Ozturk Z, Anuurad E, Berglund L. Postprandial lipoproteins and cardiovascular disease risk in diabetes mellitus. Curr Diab Rep. 2010 Feb;10(1):61-9. doi: 10.1007/s11892-009-0088-4.
PMID: 20425069BACKGROUNDKeske MA, Premilovac D, Bradley EA, Dwyer RM, Richards SM, Rattigan S. Muscle microvascular blood flow responses in insulin resistance and ageing. J Physiol. 2016 Apr 15;594(8):2223-31. doi: 10.1113/jphysiol.2014.283549. Epub 2015 Jan 12.
PMID: 25581640BACKGROUNDVincent MA, Barrett EJ, Lindner JR, Clark MG, Rattigan S. Inhibiting NOS blocks microvascular recruitment and blunts muscle glucose uptake in response to insulin. Am J Physiol Endocrinol Metab. 2003 Jul;285(1):E123-9. doi: 10.1152/ajpendo.00021.2003.
PMID: 12791603BACKGROUNDWilliams SB, Cusco JA, Roddy MA, Johnstone MT, Creager MA. Impaired nitric oxide-mediated vasodilation in patients with non-insulin-dependent diabetes mellitus. J Am Coll Cardiol. 1996 Mar 1;27(3):567-74. doi: 10.1016/0735-1097(95)00522-6.
PMID: 8606266BACKGROUNDJohnstone MT, Creager SJ, Scales KM, Cusco JA, Lee BK, Creager MA. Impaired endothelium-dependent vasodilation in patients with insulin-dependent diabetes mellitus. Circulation. 1993 Dec;88(6):2510-6. doi: 10.1161/01.cir.88.6.2510.
PMID: 8080489BACKGROUNDTessari P, Cecchet D, Cosma A, Vettore M, Coracina A, Millioni R, Iori E, Puricelli L, Avogaro A, Vedovato M. Nitric oxide synthesis is reduced in subjects with type 2 diabetes and nephropathy. Diabetes. 2010 Sep;59(9):2152-9. doi: 10.2337/db09-1772. Epub 2010 May 18.
PMID: 20484137BACKGROUNDForstermann U. Janus-faced role of endothelial NO synthase in vascular disease: uncoupling of oxygen reduction from NO synthesis and its pharmacological reversal. Biol Chem. 2006 Dec;387(12):1521-33. doi: 10.1515/BC.2006.190.
PMID: 17132097BACKGROUNDDeveaux A, Pham I, West SG, Andre E, Lantoine-Adam F, Bunouf P, Sadi S, Hermier D, Mathe V, Fouillet H, Huneau JF, Benamouzig R, Mariotti F. l-Arginine Supplementation Alleviates Postprandial Endothelial Dysfunction When Baseline Fasting Plasma Arginine Concentration Is Low: A Randomized Controlled Trial in Healthy Overweight Adults with Cardiometabolic Risk Factors. J Nutr. 2016 Jul;146(7):1330-40. doi: 10.3945/jn.115.227959. Epub 2016 Jun 8.
PMID: 27281800BACKGROUNDSchulman SP, Becker LC, Kass DA, Champion HC, Terrin ML, Forman S, Ernst KV, Kelemen MD, Townsend SN, Capriotti A, Hare JM, Gerstenblith G. L-arginine therapy in acute myocardial infarction: the Vascular Interaction With Age in Myocardial Infarction (VINTAGE MI) randomized clinical trial. JAMA. 2006 Jan 4;295(1):58-64. doi: 10.1001/jama.295.1.58.
PMID: 16391217BACKGROUNDAgarwal U, Didelija IC, Yuan Y, Wang X, Marini JC. Supplemental Citrulline Is More Efficient Than Arginine in Increasing Systemic Arginine Availability in Mice. J Nutr. 2017 Apr;147(4):596-602. doi: 10.3945/jn.116.240382. Epub 2017 Feb 8.
PMID: 28179487BACKGROUND
Results Point of Contact
- Title
- Tim Allerton, Ph.D.
- Organization
- Pennington Biomedical Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy D Allerton, PhD
Pennington Biomedical Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Fellow
Study Record Dates
First Submitted
September 15, 2019
First Posted
September 17, 2019
Study Start
September 12, 2019
Primary Completion
March 20, 2020
Study Completion
March 20, 2020
Last Updated
July 30, 2024
Results First Posted
July 30, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share