Endothelial DysfunctionWMJNCT04092439
The Effects of Watermelon Juice Supplementation on Postprandial Vascular Endothelial Function
A study testing Watermelon Juice in people with Endothelial Dysfunction, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The purpose of this study is to test if watermelon juice supplementation improves vascular dysfunction experience during hyperglycemia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Watermelon Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2019to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable and willing to give written informed consent and understand inclusion and exclusion criteria.
- 18-40 years of age
- BMI between 18-29.9 kg/m2
- Willing to allow researchers to draw blood and conduct imaging (DXA) for research purposes.
Who cannot join
- 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
Show all 15Show fewer
- Anti-diabetics (metformin)
- Corticosteroids
- Beta-blockers
- Anti-coagulates
- Use of supplements known to influence study outcomes, such as;
- Beta-alanine
- L-arginine
- L-citrulline
- Active smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: The Effects of Watermelon Juice Supplementation on Postprandial Vascular Endothelial Function and Blood Flow During Hyperglycemia: A Pilot Study
The purpose of this study is to test if watermelon juice supplementation improves vascular dysfunction experience during hyperglycemia.
Read the detailed description
The objective of this pilot study is to determine the potential for watermelon juice to attenuate the reduction postprandial endothelial function and skeletal muscle microvascular blood flow (MVBF) experienced during hyperglycemia.
The investigators will attempt to answer the following hypotheses:
Hypothesis 1: Watermelon juice supplementation will attenuate the reduction in endothelial dysfunction and microvascular blood flow during an oral glucose challenge.
Hypothesis 2: Watermelon juice will increase L-arginine bioavailability during hyperglycemia and correlate with improved vascular response.
Exploratory Aim: The postprandial period is defined by increased sympathetic nervous system activity (vasoconstriction) and NO• mediated vasodilation. Heart rate variability (HRV) is a measurement of the balance of parasympathetic to sympathetic activity. The investigators will measure HRV during the oral glucose challenge to interrogate the possibility that watermelon juice can modulate the balance of blood vessel constriction and relaxation during an oral glucose
Procedures Involved
There will be 1 screening visit, and 2 outpatient visits. Participants will consume watermelon juice or placebo for 2 weeks. The washout period will last 2 weeks prior to the cross-over to the opposite condition. Participants visits will be conducted at the Vascular and Resting Metabolism Lab located in the department of kinesiology at LSU.
Screening Visit
Participants will undergo consenting and fasting blood draws to measure glucose, lipids, and CBC. Vital signs (blood pressure, body weight, body composition (DXA), heart rate, etc) will be measured. For DXA procedure participants will undergo a whole body scan lasting approximately 10 minutes. Participants will remove all metal objects from their body and lie down on the table. The legs will be secured together using two Velcro straps. The participant will be instructed to remain completely still during the scan. Randomization will be performed to allocate the study participant for their initial group assignment to either the watermelon juice group or placebo. The initial six participants will be assigned treatment A for phase 1 and treatment B for phase 2, thereafter the following 6 will be assigned treatment B first then treatment A. The remaining participant will be randomly assigned either treatment A or B in a counterbalanced fashion.
Daily Juice Drop-in visits
Since the required supplementation duration is 14 days participants will be provided with 2 days (Saturday and Sunday) worth of watermelon juice or placebo to account for days when the LSU AG Center will not be open. To allow for scheduling conflicts and unforeseen circumstances a 3 day period of supplementation less then or greater than the 14 periods will be permitted. Participants will also be provided with juice or placebo for anticipated instances where they cannot be on campus. In order to monitor compliance participants will be asked return the juice container for the days where juice was consumed off premises.
Visit 2 and 3: Oral Glucose Challenge - Postprandial FMD and MVBF
Participants will arrive in morning at 6:00am fasted for 10-hours. Body composition will be measured by DXA. Next, participants will rest for 30 minutes in the supine positing while wearing a heart rate monitor (Zephyr, Bioharness) to measure heart rate and heart rate variability. Resting metabolic rate will be measured via indirect calorimetry for 20 minutes. Then fasting measures of blood glucose, FMD (ultrasound) and MVBF (near-infrared spectroscopy) will be taken followed by ingestion of 75 g of glucose (glucola). An IV line will be placed in the participants arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn, and then the participant will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after the participant consumes the drink. Each blood sample will be about 1 tablespoon. (6 tablespoons total for the test). During the IV procedure, a small amount of the participant's own blood (less than 1 teaspoon) will immediately be returned into the participants vein through the IV after each specimen is collected. Blood will be drawn at minute 15, 30, 60, 90, 120 minutes. Postprandial measurements of FMD and MVBF will be taken at 30, 60, 90, and 120 minutes.
- Conditions
- Endothelial Dysfunction
- Being tested
- Watermelon Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watermelon JuiceDietary supplement
100% Watermelon Juice
| Study group | Role | What they receive |
|---|---|---|
| Watermelon juice | Experimental | The study participants consumed 500 ml of 100% watermelon juice for two weeks Receives: Dietary Supplement: Watermelon Juice |
| Placebo | Placebo comparator | The study participants consumed a watermelon flavored, fructose matched control Receives: Dietary Supplement: Watermelon Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Flow mediated dilation
Measured: Two weeks
Secondary outcomes (1)
Postprandial Blood Flow
microvascular blood flow
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start12 Sep 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Allerton, PhD, Pennington Biomedical Research Center
- Investigators
- Timothy D Allerton, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092439
- Sponsor's protocol ID
- PBRC 2019-024
- Acronym
- WMJ
- Status last verified
- Jul 2024
- First submitted
- 15 Sep 2019
- Last updated
- 30 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27493134Berrington 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.
PubMed 21121834Avogaro A. Postprandial glucose: marker or risk factor? Diabetes Care. 2011 Oct;34(10):2333-5. doi: 10.2337/dc11-1442. No abstract available.
PubMed 21949226Enkhmaa 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.
PubMed 20425069Keske 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.
PubMed 25581640Vincent 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.
PubMed 12791603Williams 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.
PubMed 8606266Johnstone 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.
PubMed 8080489Tessari 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.
PubMed 20484137Forstermann 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.
PubMed 17132097Deveaux 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.
PubMed 27281800Schulman 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.
PubMed 16391217Agarwal 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.
PubMed 28179487
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Watermelon Juice Supplementation on Postprandial Vascular Endothelial Function and Blood Flow During Hyperglycemia: A Pilot Study
- ClinicalTrials.gov ID
- NCT04092439
- Acronym / sponsor ID
- WMJ / PBRC 2019-024
- Conditions
- Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Posted 30 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test if watermelon juice supplementation improves vascular dysfunction experience during hyperglycemia.
Detailed description
The objective of this pilot study is to determine the potential for watermelon juice to attenuate the reduction postprandial endothelial function and skeletal muscle microvascular blood flow (MVBF) experienced during hyperglycemia.
The investigators will attempt to answer the following hypotheses:
Hypothesis 1: Watermelon juice supplementation will attenuate the reduction in endothelial dysfunction and microvascular blood flow during an oral glucose challenge.
Hypothesis 2: Watermelon juice will increase L-arginine bioavailability during hyperglycemia and correlate with improved vascular response.
Exploratory Aim: The postprandial period is defined by increased sympathetic nervous system activity (vasoconstriction) and NO• mediated vasodilation. Heart rate variability (HRV) is a measurement of the balance of parasympathetic to sympathetic activity. The investigators will measure HRV during the oral glucose challenge to interrogate the possibility that watermelon juice can modulate the balance of blood vessel constriction and relaxation during an oral glucose
Procedures Involved
There will be 1 screening visit, and 2 outpatient visits. Participants will consume watermelon juice or placebo for 2 weeks. The washout period will last 2 weeks prior to the cross-over to the opposite condition. Participants visits will be conducted at the Vascular and Resting Metabolism Lab located in the department of kinesiology at LSU.
Screening Visit
Participants will undergo consenting and fasting blood draws to measure glucose, lipids, and CBC. Vital signs (blood pressure, body weight, body composition (DXA), heart rate, etc) will be measured. For DXA procedure participants will undergo a whole body scan lasting approximately 10 minutes. Participants will remove all metal objects from their body and lie down on the table. The legs will be secured together using two Velcro straps. The participant will be instructed to remain completely still during the scan. Randomization will be performed to allocate the study participant for their initial group assignment to either the watermelon juice group or placebo. The initial six participants will be assigned treatment A for phase 1 and treatment B for phase 2, thereafter the following 6 will be assigned treatment B first then treatment A. The remaining participant will be randomly assigned either treatment A or B in a counterbalanced fashion.
Daily Juice Drop-in visits
Since the required supplementation duration is 14 days participants will be provided with 2 days (Saturday and Sunday) worth of watermelon juice or placebo to account for days when the LSU AG Center will not be open. To allow for scheduling conflicts and unforeseen circumstances a 3 day period of supplementation less then or greater than the 14 periods will be permitted. Participants will also be provided with juice or placebo for anticipated instances where they cannot be on campus. In order to monitor compliance participants will be asked return the juice container for the days where juice was consumed off premises.
Visit 2 and 3: Oral Glucose Challenge - Postprandial FMD and MVBF
Participants will arrive in morning at 6:00am fasted for 10-hours. Body composition will be measured by DXA. Next, participants will rest for 30 minutes in the supine positing while wearing a heart rate monitor (Zephyr, Bioharness) to measure heart rate and heart rate variability. Resting metabolic rate will be measured via indirect calorimetry for 20 minutes. Then fasting measures of blood glucose, FMD (ultrasound) and MVBF (near-infrared spectroscopy) will be taken followed by ingestion of 75 g of glucose (glucola). An IV line will be placed in the participants arm vein for blood draw purposes and will remain there throughout the testing. A blood sample will be drawn, and then the participant will drink a sugar solution consisting of 75 grams of glucose. Blood will be drawn at specific times after the participant consumes the drink. Each blood sample will be about 1 tablespoon. (6 tablespoons total for the test). During the IV procedure, a small amount of the participant's own blood (less than 1 teaspoon) will immediately be returned into the participants vein through the IV after each specimen is collected. Blood will be drawn at minute 15, 30, 60, 90, 120 minutes. Postprandial measurements of FMD and MVBF will be taken at 30, 60, 90, and 120 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watermelon juice | Experimental | Dietary Supplement: Watermelon JuiceThe study participants consumed 500 ml of 100% watermelon juice for two weeks |
| Placebo | Placebo comparator | Dietary Supplement: Watermelon JuiceThe study participants consumed a watermelon flavored, fructose matched control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Capable and willing to give written informed consent and understand inclusion and exclusion criteria.
- 18-40 years of age
- BMI between 18-29.9 kg/m2
- Willing to allow researchers to draw blood and conduct imaging (DXA) for research purposes.
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watermelon Juice100% Watermelon Juice | Dietary supplement | Placebo, Watermelon juice |
Primary outcome
Endothelial Function
Time frame: Two weeks
Flow mediated dilation
1 secondary outcome
Postprandial Blood Flow
Time frame: Two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27493134Baena-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.
- Background: PubMed 21121834Berrington 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.
- Background: PubMed 21949226Avogaro A. Postprandial glucose: marker or risk factor? Diabetes Care. 2011 Oct;34(10):2333-5. doi: 10.2337/dc11-1442. No abstract available.
- Background: PubMed 20425069Enkhmaa 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.
- Background: PubMed 25581640Keske 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.
- Background: PubMed 12791603Vincent 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.
- Background: PubMed 8606266Williams 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.
- Background: PubMed 8080489Johnstone 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.
- Background: PubMed 20484137Tessari 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.
- Background: PubMed 17132097Forstermann 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.
- Background: PubMed 27281800Deveaux 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.
- Background: PubMed 16391217Schulman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy D Allerton, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watermelon Juice in people with Endothelial Dysfunction, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092439, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.