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Watermelon and Beetroot Products on Endothelial Function

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ClinicalTrials.gov Identifier: NCT04781595
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Thiago Alvares, Universidade Federal do Rio de Janeiro

Study Description
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Brief Summary:
Cardiovascular disease is the main cause of death worldwide. Endothelial dysfunction is the first step to development of cardiovascular diseases. Endothelial dysfunction occurs due to reduction in nitric oxide, a molecule that plays an important role on vascular health. Due to important role of nitric oxide in endothelial function, several studies have evaluated the effect of its precursors, such as L-citrulline and nitrate on endothelial function parameters. The present study will evaluate the effect of L-citrulline and nitrate derived by watermelon and beetroot products, respectively, on endothelial function of young and older participants. Furthermore, we will evaluate the plasmatic amino acids, nitrate, glucose and insulin in response to ingestion of these products.

Condition or disease Intervention/treatment Phase
Healthy Young Older People With Cardiovascular Disease Risk Dietary Supplement: Watermelon Dietary Supplement: Beetroot Dietary Supplement: Watermelon + beetroot Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Watermelon and Beetroot Products on Endothelial Function in Young and Older Adults
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Watermelon
Watermelon powder containing 3 g of L-citrulline.
 Dietary Supplement: Watermelon
A single dose of watermelon powder containing 3g of L-citrulline
Active Comparator: Beetroot
Beetroot powder containing 8 mmol of nitrate.
 Dietary Supplement: Beetroot
A single dose of beetroot powder containing 8 mmol of nitrate
Active Comparator: Watermelon + beetroot
Watermelon powder containing 3 g of L-citrulline and Beetroot powder containing 8 mmol of nitrate.
 Dietary Supplement: Watermelon + beetroot
A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate
Placebo Comparator: Placebo
Maltodextrin
 Dietary Supplement: Placebo
A single dose of maltodextrin


Outcome Measures
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Primary Outcome Measures :
  1. Flow-mediated dilation (FMD) [ Time Frame: This measure will be evaluate before the nutritional intervention ]
  2. Flow-mediated dilation (FMD) [ Time Frame: This measure will be evaluate 60 minutes after the nutritional intervention ]
  3. Flow-mediated dilation (FMD) [ Time Frame: This measure will be evaluate 120 minutes after the nutritional intervention ]
  4. Muscle oxygen saturation [ Time Frame: This measure will be evaluate before the nutritional intervention ]
  5. Muscle oxygen saturation [ Time Frame: This measure will be evaluate 30 minutes after the nutritional intervention ]
  6. Muscle oxygen saturation [ Time Frame: This measure will be evaluate 60 minutes after the nutritional intervention ]
  7. Muscle oxygen saturation [ Time Frame: This measure will be evaluate 90 minutes after the nutritional intervention ]
  8. Muscle oxygen saturation [ Time Frame: This measure will be evaluate 120 minutes after the nutritional intervention ]

Secondary Outcome Measures :
  1. Plasmatic amino acids [ Time Frame: This measure will be evaluate before the nutritional intervention ]
  2. Plasmatic amino acids [ Time Frame: This measure will be evaluate 30 minutes after the nutritional intervention ]
  3. Plasmatic amino acids [ Time Frame: This measure will be evaluate 60 minutes after the nutritional intervention ]
  4. Plasmatic amino acids [ Time Frame: This measure will be evaluate 90 minutes after the nutritional intervention ]
  5. Plasmatic amino acids [ Time Frame: This measure will be evaluate 120 minutes after the nutritional intervention ]
  6. Plasmatic glucose [ Time Frame: This measure will be evaluate before the nutritional intervention ]
  7. Plasmatic glucose [ Time Frame: This measure will be evaluate 30 min after the nutritional intervention ]
  8. Plasmatic glucose [ Time Frame: This measure will be evaluate 60 min after the nutritional intervention ]
  9. Plasmatic glucose [ Time Frame: This measure will be evaluate 90 min after the nutritional intervention ]
  10. Plasmatic glucose [ Time Frame: This measure will be evaluate 120 min after the nutritional intervention ]
  11. Plasmatic insulin [ Time Frame: This measure will be evaluate before the nutritional intervention ]
  12. Plasmatic insulin [ Time Frame: This measure will be evaluate 30 min after the nutritional intervention ]
  13. Plasmatic insulin [ Time Frame: This measure will be evaluate 60 min after the nutritional intervention ]
  14. Plasmatic insulin [ Time Frame: This measure will be evaluate 90 min after the nutritional intervention ]
  15. Plasmatic insulin [ Time Frame: This measure will be evaluate 120 min after the nutritional intervention ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for healthy young participants:

  • Age between 18-35 years;
  • Triglycerides ≤ 150 mg/dL
  • HDL-cholesterol ≥ 50 mg/dL for women and ≥ 40 mg/dL for men;
  • Waist circumference ≤ 102 cm for men and ≤ 88 cm for women).

Inclusion Criteria for older people with cardiovascular risk:

  • Age ≥ 60 years;
  • Elevated triglycerides ≥150 mg/dL;
  • Reduced HDL-cholesterol ≤ 50 mg/dL for women and ≤ 40 mg/dL for men;
  • Elevated waist circumference ≥102 cm for men and ≥ 88 cm for women).

Exclusion Criteria:

  • Elevated fasting glucose (≥100 mg/dL);
  • Smoking;
  • Beetroot or watermelon allergy;
  • Unwillingness to avoid beetroot or watermelon products during the entire study;
  • Other chronic diseases (diabetes, liver disease, etc.) or acutely ill
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04781595


Contacts
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Contact: Thiago Alvares, PhD +5521999896554 alvares@macae.ufrj.br
Contact: Mônica Souza, Master +5522998623136 mvolinosouza@gmail.com

Locations
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Brazil
Universidade Federal do Rio de Janeiro Recruiting
Macaé, Rio De Janeiro, Brazil, 27979-000
Contact: Thiago Alvares, PhD    +5521999896554    alvares@macae.ufrj.br   
Contact: Mônica Souza, Master    +5522998623136    mvolinosouza@gmail.com   
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Principal Investigator: Thiago Alvares, PhD Universidade Federal do Rio de Janeiro
More Information
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Responsible Party: Thiago Alvares, Principal Investigator, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT04781595    
Other Study ID Numbers: E-26/202.905/2019
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: April 14, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thiago Alvares, Universidade Federal do Rio de Janeiro:
endothelial function
L-citrulline
nitrate
nitric oxide
Additional relevant MeSH terms:
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Cardiovascular Diseases