NCT04092439

Brief Summary

The purpose of this study is to test if watermelon juice supplementation improves vascular dysfunction experience during hyperglycemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

July 30, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

September 15, 2019

Results QC Date

April 21, 2023

Last Update Submit

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

EXPERIMENTAL

The study participants consumed 500 ml of 100% watermelon juice for two weeks

Dietary Supplement: Watermelon Juice

Placebo

PLACEBO COMPARATOR

The study participants consumed a watermelon flavored, fructose matched control

Dietary Supplement: Watermelon Juice

Interventions

Watermelon JuiceDIETARY_SUPPLEMENT

100% Watermelon Juice

PlaceboWatermelon juice

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 27493134BACKGROUND
  • Berrington 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: 21121834BACKGROUND
  • Avogaro A. Postprandial glucose: marker or risk factor? Diabetes Care. 2011 Oct;34(10):2333-5. doi: 10.2337/dc11-1442. No abstract available.

    PMID: 21949226BACKGROUND
  • Enkhmaa 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: 20425069BACKGROUND
  • Keske 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: 25581640BACKGROUND
  • Vincent 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: 12791603BACKGROUND
  • Williams 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: 8606266BACKGROUND
  • Johnstone 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: 8080489BACKGROUND
  • Tessari 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: 20484137BACKGROUND
  • Forstermann 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: 17132097BACKGROUND
  • Deveaux 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: 27281800BACKGROUND
  • Schulman 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: 16391217BACKGROUND
  • Agarwal 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

  • Timothy D Allerton, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

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

Locations