Water Ingestion for Heart Transplant Patients

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Satish R. Raj

Disqualifiers: Tricuspid regurgitation, Advanced renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

What is the purpose of this trial?

In this study the investigators propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will increase the systemic vascular resistance.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Water, Watermelon Juice, Citrulline-rich Watermelon Juice for heart transplant patients?

Research shows that watermelon juice, which is rich in L-citrulline, can increase nitric oxide levels in the body. Nitric oxide helps improve blood flow and may support heart health, which could be beneficial for heart transplant patients. ^{1 2 3 4 5}

Is watermelon juice safe for human consumption?

Research shows that watermelon juice, which contains compounds like citrulline and arginine, is generally safe for human consumption and has been studied for its effects on blood flow and heart health. ^{3 4 5 6 7}

How does water ingestion differ from other treatments for heart transplant patients?

Water ingestion for heart transplant patients is unique because it focuses on hydration, which is not a standard treatment for this condition. Unlike medications or surgical interventions, this approach may help improve overall health and recovery by ensuring adequate fluid intake, potentially supporting cardiovascular function. ^{3 6 7 8 9}

Research Team

Satish R Raj, MD, MSCI

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for heart transplant patients over 18 years old who are scheduled for a clinical right heart catheterization. It's not suitable for those with significant tricuspid regurgitation, difficulty swallowing large amounts of water, or severe kidney disease where drinking water could be harmful.

Inclusion Criteria

I have had a heart transplant and am scheduled for a heart catheterization.

I am over 18 years old.

Exclusion Criteria

I have severe leakage in my heart's tricuspid valve.

I have a serious health condition like advanced kidney disease.

I cannot safely drink 500 ml of water.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants ingest 16 fl oz of water and undergo hemodynamic measurements

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Water

Trial Overview The study is examining the effects of drinking 16 fl oz of water on blood vessel resistance in heart transplant recipients. The goal is to see if consuming this amount of water will increase the resistance in systemic blood vessels.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

water ingestion

Who Is Running the Clinical Trial?

Satish R. Raj

Lead Sponsor

Trials

7

Recruited

690+

National Center for Research Resources (NCRR)

Collaborator

Trials

540

Recruited

317,000+

Findings from Research

In a study with low-density lipoprotein receptor-deficient mice, consumption of watermelon extract ('sentinel') for 12 weeks significantly reduced body weight gain and plasma cholesterol levels, particularly intermediate-/low-density lipoprotein cholesterol.

The extract also improved the balance of pro- and anti-inflammatory cytokines, leading to a reduction in atherosclerosis development in the aortic arch and thoracic regions, without affecting systolic blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Citrullus lanatus 'sentinel' (watermelon) extract reduces atherosclerosis in LDL receptor-deficient mice. Poduri, A., Rateri, DL., Saha, SK., et al.[2021]

Watermelon and its key compound L-citrulline have been shown to reduce blood pressure in human trials, indicating potential cardiovascular benefits.

Emerging evidence suggests that watermelon intake may improve lipid metabolism and glucose homeostasis, with additional benefits for gut health and satiety, although more research is needed to confirm these effects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Watermelon and L-Citrulline in Cardio-Metabolic Health: Review of the Evidence 2000-2020. Burton-Freeman, B., Freeman, M., Zhang, X., et al.[2023]

Watermelon juice supplementation significantly increased plasma levels of l-citrulline, l-arginine, and nitrite, which are associated with improved nitric oxide bioavailability, but it also raised resting blood pressure compared to control conditions.

Despite the benefits in muscle oxygenation during moderate-intensity exercise, watermelon juice did not enhance time-to-exhaustion during severe-intensity exercise, suggesting it may not be effective for improving endurance performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two weeks of watermelon juice supplementation improves nitric oxide bioavailability but not endurance exercise performance in humans. Bailey, SJ., Blackwell, JR., Williams, E., et al.[2018]

Watermelon juice, especially when unpasteurized, enhances the bioavailability of l-citrulline, which is beneficial for reducing muscle soreness in athletes.

In a study with seven athletes, both natural and enriched watermelon juices significantly lowered recovery heart rates and muscle soreness after intense exercise, suggesting their effectiveness as functional drinks for athletic recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Watermelon juice: potential functional drink for sore muscle relief in athletes. Tarazona-Díaz, MP., Alacid, F., Carrasco, M., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Citrullus lanatus 'sentinel' (watermelon) extract reduces atherosclerosis in LDL receptor-deficient mice. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Watermelon and L-Citrulline in Cardio-Metabolic Health: Review of the Evidence 2000-2020. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Two weeks of watermelon juice supplementation improves nitric oxide bioavailability but not endurance exercise performance in humans. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Parameters of Watermelon (Rind, Flesh, and Seeds) Bioactive Components in Human Plasma: A Pilot Study to Investigate the Relationship to Endothelial Function. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effect of microencapsulated watermelon (Citrullus Lanatus) rind on flow-mediated dilation and tissue oxygen saturation of young adults. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Daily 100% watermelon juice consumption and vascular function among postmenopausal women: A randomized controlled trial. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Impact of microencapsulated watermelon (Citrullus lanatus) and beetroot (Beta vulgaris L) on storage stability of l-citrulline and dietary nitrate. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Watermelon juice: potential functional drink for sore muscle relief in athletes. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Determination of citrulline in watermelon rind. [2019]