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Completed

NCT Number: NCT04781595

Watermelon and Beetroot Products on Endothelial Function

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio de Janeiro

Macaé, Rio de Janeiro, 27979-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Watermelon

Dietary Supplement

A single dose of watermelon powder containing 3g of L-citrulline

Beetroot

Dietary Supplement

A single dose of beetroot powder containing 8 mmol of nitrate

Watermelon + beetroot

Dietary Supplement

A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate

Placebo

Dietary Supplement

A single dose of maltodextrin

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

Effect of Watermelon and Beetroot Products on Endothelial Function in Young and Older Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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