Clinical trial NCT04781595: Watermelon and Beetroot Products on Endothelial Function
Official title: Effect of Watermelon and Beetroot Products on Endothelial Function in Young and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young
Older People With Cardiovascular Disease Risk
Keywords: endothelial function
L-citrulline
nitrate
nitric oxide
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Flow-mediated dilation (FMD)
timeFrame: This measure will be evaluate before the nutritional intervention
measure: Flow-mediated dilation (FMD)
timeFrame: This measure will be evaluate 60 minutes after the nutritional intervention
measure: Flow-mediated dilation (FMD)
timeFrame: This measure will be evaluate 120 minutes after the nutritional intervention
measure: Muscle oxygen saturation
timeFrame: This measure will be evaluate before the nutritional intervention
measure: Muscle oxygen saturation
timeFrame: This measure will be evaluate 30 minutes after the nutritional intervention
measure: Muscle oxygen saturation
timeFrame: This measure will be evaluate 60 minutes after the nutritional intervention
measure: Muscle oxygen saturation
timeFrame: This measure will be evaluate 90 minutes after the nutritional intervention
measure: Muscle oxygen saturation
timeFrame: This measure will be evaluate 120 minutes after the nutritional intervention
Secondary outcomes:
measure: Plasmatic amino acids
timeFrame: This measure will be evaluate before the nutritional intervention
measure: Plasmatic amino acids
timeFrame: This measure will be evaluate 30 minutes after the nutritional intervention
measure: Plasmatic amino acids
timeFrame: This measure will be evaluate 60 minutes after the nutritional intervention
measure: Plasmatic amino acids
timeFrame: This measure will be evaluate 90 minutes after the nutritional intervention
measure: Plasmatic amino acids
timeFrame: This measure will be evaluate 120 minutes after the nutritional intervention
measure: Plasmatic glucose
timeFrame: This measure will be evaluate before the nutritional intervention
measure: Plasmatic glucose
timeFrame: This measure will be evaluate 30 min after the nutritional intervention
measure: Plasmatic glucose
timeFrame: This measure will be evaluate 60 min after the nutritional intervention
measure: Plasmatic glucose
timeFrame: This measure will be evaluate 90 min after the nutritional intervention
measure: Plasmatic glucose
timeFrame: This measure will be evaluate 120 min after the nutritional intervention
measure: Plasmatic insulin
timeFrame: This measure will be evaluate before the nutritional intervention
measure: Plasmatic insulin
timeFrame: This measure will be evaluate 30 min after the nutritional intervention
measure: Plasmatic insulin
timeFrame: This measure will be evaluate 60 min after the nutritional intervention
measure: Plasmatic insulin
timeFrame: This measure will be evaluate 90 min after the nutritional intervention
measure: Plasmatic insulin
timeFrame: This measure will be evaluate 120 min after the nutritional intervention
Other outcomes:
Locations:
city: Macaé
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: Rio De Janeiro
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Thiago Alvares, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.