Watermelon and Beetroot Products on Endothelial Function

Healthy Young Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781595
• Other study ID #: E-26/202.905/2019
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2022
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Healthy Young
• Older People With Cardiovascular Disease Risk

Intervention

Dietary Supplement:
• Watermelon
A single dose of watermelon powder containing 3g of L-citrulline
• Beetroot
A single dose of beetroot powder containing 8 mmol of nitrate
• Watermelon + beetroot
A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate
• Placebo
A single dose of maltodextrin

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio de Janeiro	Macaé	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation (FMD)		This measure will be evaluate before the nutritional intervention
Primary	Flow-mediated dilation (FMD)		This measure will be evaluate 60 minutes after the nutritional intervention
Primary	Flow-mediated dilation (FMD)		This measure will be evaluate 120 minutes after the nutritional intervention
Primary	Muscle oxygen saturation		This measure will be evaluate before the nutritional intervention
Primary	Muscle oxygen saturation		This measure will be evaluate 30 minutes after the nutritional intervention
Primary	Muscle oxygen saturation		This measure will be evaluate 60 minutes after the nutritional intervention
Primary	Muscle oxygen saturation		This measure will be evaluate 90 minutes after the nutritional intervention
Primary	Muscle oxygen saturation		This measure will be evaluate 120 minutes after the nutritional intervention
Secondary	Plasmatic amino acids		This measure will be evaluate before the nutritional intervention
Secondary	Plasmatic amino acids		This measure will be evaluate 30 minutes after the nutritional intervention
Secondary	Plasmatic amino acids		This measure will be evaluate 60 minutes after the nutritional intervention
Secondary	Plasmatic amino acids		This measure will be evaluate 90 minutes after the nutritional intervention
Secondary	Plasmatic amino acids		This measure will be evaluate 120 minutes after the nutritional intervention
Secondary	Plasmatic glucose		This measure will be evaluate before the nutritional intervention
Secondary	Plasmatic glucose		This measure will be evaluate 30 min after the nutritional intervention
Secondary	Plasmatic glucose		This measure will be evaluate 60 min after the nutritional intervention
Secondary	Plasmatic glucose		This measure will be evaluate 90 min after the nutritional intervention
Secondary	Plasmatic glucose		This measure will be evaluate 120 min after the nutritional intervention
Secondary	Plasmatic insulin		This measure will be evaluate before the nutritional intervention
Secondary	Plasmatic insulin		This measure will be evaluate 30 min after the nutritional intervention
Secondary	Plasmatic insulin		This measure will be evaluate 60 min after the nutritional intervention
Secondary	Plasmatic insulin		This measure will be evaluate 90 min after the nutritional intervention
Secondary	Plasmatic insulin		This measure will be evaluate 120 min after the nutritional intervention