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NCT04781595

Watermelon and Beetroot Products on Endothelial Function

NCT ID: NCT04781595

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-07-31

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.

Detailed Description

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Conditions

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Healthy Young Older People With Cardiovascular Disease Risk

Keywords

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endothelial function L-citrulline nitrate nitric oxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Watermelon

Watermelon powder containing 3 g of L-citrulline.

Group Type ACTIVE_COMPARATOR

Watermelon

Intervention Type DIETARY_SUPPLEMENT

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

Beetroot

Beetroot powder containing 8 mmol of nitrate.

Group Type ACTIVE_COMPARATOR

Beetroot

Intervention Type DIETARY_SUPPLEMENT

A single dose of beetroot powder containing 8 mmol of nitrate

Watermelon + beetroot

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

Group Type ACTIVE_COMPARATOR

Watermelon + beetroot

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A single dose of maltodextrin

Interventions

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Watermelon

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

Intervention Type DIETARY_SUPPLEMENT

Beetroot

A single dose of beetroot powder containing 8 mmol of nitrate

Intervention Type DIETARY_SUPPLEMENT

Watermelon + beetroot

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

A single dose of maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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).

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Thiago Alvares

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thiago Alvares, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

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Universidade Federal do Rio de Janeiro

Macaé, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED

PMID: 37561087 (View on PubMed)

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.

Reference Type DERIVED

PMID: 36109652 (View on PubMed)

Other Identifiers

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E-26/202.905/2019

Identifier Type: -

Identifier Source: org_study_id