Watermelon and Beetroot Products on Endothelial Function

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Young, Older People With Cardiovascular Disease Risk

Intervention / Treatment
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* Dietary Supplement: Watermelon
* Dietary Supplement: Beetroot
* Dietary Supplement: Watermelon + beetroot
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Watermelon<br>Watermelon powder containing 3 g of L-citrulline. | Dietary Supplement: Watermelon<br>* A single dose of watermelon powder containing 3g of L-citrulline<br>|
| Active Comparator: Beetroot<br>Beetroot powder containing 8 mmol of nitrate. | Dietary Supplement: Beetroot<br>* A single dose of beetroot powder containing 8 mmol of nitrate<br>|
| Active Comparator: Watermelon + beetroot<br>Watermelon powder containing 3 g of L-citrulline and Beetroot powder containing 8 mmol of nitrate. | Dietary Supplement: Watermelon + beetroot<br>* A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate<br>|
| Placebo Comparator: Placebo<br>Maltodextrin | Dietary Supplement: Placebo<br>* A single dose of maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Plasmatic glucose |  | This measure will be evaluate before the nutritional intervention | 
| Plasmatic glucose |  | This measure will be evaluate 30 min after the nutritional intervention | 
| Plasmatic glucose |  | This measure will be evaluate 60 min after the nutritional intervention | 
| Plasmatic glucose |  | This measure will be evaluate 90 min after the nutritional intervention | 
| Plasmatic glucose |  | This measure will be evaluate 120 min after the nutritional intervention | 
| Plasmatic insulin |  | This measure will be evaluate before the nutritional intervention | 
| Plasmatic insulin |  | This measure will be evaluate 30 min after the nutritional intervention | 
| Plasmatic insulin |  | This measure will be evaluate 60 min after the nutritional intervention | 
| Plasmatic insulin |  | This measure will be evaluate 90 min after the nutritional intervention | 
| Plasmatic insulin |  | This measure will be evaluate 120 min after the nutritional intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, L-citrulline, nitrate, nitric oxide