Watermelon and Beetroot Products on Endothelial Function

NCT04781595 | Completed

• 1 other identifier: E-26/202.905/2019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Young; Older People With Cardiovascular Disease Risk

Keywords

endothelial function; L-citrulline; nitrate; nitric oxide

Outcome Measures

Primary Outcomes (8)

• Flow-mediated dilation (FMD)

  This measure will be evaluate before the nutritional intervention

• Flow-mediated dilation (FMD)

  This measure will be evaluate 60 minutes after the nutritional intervention

• Flow-mediated dilation (FMD)

  This measure will be evaluate 120 minutes after the nutritional intervention

• Muscle oxygen saturation

  This measure will be evaluate before the nutritional intervention

• Muscle oxygen saturation

  This measure will be evaluate 30 minutes after the nutritional intervention

• Muscle oxygen saturation

  This measure will be evaluate 60 minutes after the nutritional intervention

• Muscle oxygen saturation

  This measure will be evaluate 90 minutes after the nutritional intervention

• Muscle oxygen saturation

  This measure will be evaluate 120 minutes after the nutritional intervention

Secondary Outcomes (15)

• Plasmatic amino acids

  This measure will be evaluate before the nutritional intervention

• Plasmatic amino acids

  This measure will be evaluate 30 minutes after the nutritional intervention

• Plasmatic amino acids

  This measure will be evaluate 60 minutes after the nutritional intervention

• Plasmatic amino acids

  This measure will be evaluate 90 minutes after the nutritional intervention

• Plasmatic amino acids

  This measure will be evaluate 120 minutes after the nutritional intervention

Study Arms (4)

Watermelon

ACTIVE COMPARATOR

Watermelon powder containing 3 g of L-citrulline.

Dietary Supplement: Watermelon

Beetroot

ACTIVE COMPARATOR

Beetroot powder containing 8 mmol of nitrate.

Dietary Supplement: Beetroot

Watermelon + beetroot

ACTIVE COMPARATOR

Watermelon powder containing 3 g of L-citrulline and Beetroot powder containing 8 mmol of nitrate.

Dietary Supplement: Watermelon + beetroot

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Watermelon DIETARY_SUPPLEMENT

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

Watermelon

Beetroot DIETARY_SUPPLEMENT

A single dose of beetroot powder containing 8 mmol of nitrate

Beetroot

Watermelon + beetroot DIETARY_SUPPLEMENT

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

Watermelon + beetroot

Placebo DIETARY_SUPPLEMENT

A single dose of maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Universidade Federal do Rio de Janeiro

Macaé, Rio de Janeiro, 27979-000, Brazil

Location

Related Publications (2)

• Volino-Souza M, Oliveira GV, Tavares AC, Souza K, Alvares T. The effect of microencapsulated watermelon rind (Citrullus lanatus) and beetroot (Beta vulgaris L.) ingestion on ischemia/reperfusion-induced endothelial dysfunction: a randomised clinical trial. Food Funct. 2023 Aug 29;14(17):7959-7968. doi: 10.1039/d3fo02612d.

  PMID: 37561087 DERIVED

• Volino-Souza M, de Oliveira GV, Conte-Junior CA, Alvares TS. Effect of microencapsulated watermelon (Citrullus Lanatus) rind on flow-mediated dilation and tissue oxygen saturation of young adults. Eur J Clin Nutr. 2023 Jan;77(1):71-74. doi: 10.1038/s41430-022-01200-8. Epub 2022 Sep 15.

  PMID: 36109652 DERIVED

Study Officials

• Thiago Alvares, PhD

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 4, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

BR (1)