The Effects of Watermelon Juice Supplementation on Postprandial Vascular Endothelial Function

Endothelial Dysfunction Clinical Trial

— WMJ  

Official title:

The Effects of Watermelon Juice Supplementation on Postprandial Vascular Endothelial Function and Blood Flow During Hyperglycemia: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092439
• Other study ID #: PBRC2019024
• Status: Completed
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: March 20, 2020

Study information

• Verified date: May 2020
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

We 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. We 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 you consume 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 your 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Capable and willing to give written informed consent and understand inclusion and exclusion criteria.

2. 18-40 years of age

3. BMI between 18-29.9 kg/m2

4. Willing to allow researchers to draw blood and conduct imaging (DXA) for research purposes.

Exclusion Criteria:

1. Evidence or self-reported history of type 1 or 2 diabetes mellitus

2. Self-reported family history of type 2 diabetes (first degree relative with type 2 diabetes)

3. Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease

4. Allergy to watermelon

5. Use of medication known to influence study outcomes, such as:

1. Insulin

2. Anti-diabetics (metformin)

3. Corticosteroids

4. Beta-blockers

5. Anti-coagulates

6. Use of supplements known to influence study outcomes, such as;

1. Beta-alanine

2. L-arginine

3. L-citrulline

7. Active smoking

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Dietary Supplement:
• Watermelon Juice
100% Watermelon Juice

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

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Förstermann 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Function	Flow mediated dilation	Two weeks
Secondary	Postprandial Blood Flow	microvascular blood flow	Two weeks