Healthy YoungNCT04781595

Watermelon and Beetroot Products on Endothelial Function

A study testing Watermelon, Beetroot and Watermelon + beetroot in people with Healthy Young and Older People With Cardiovascular Disease Risk, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Young, Older People With Cardiovascular Disease Risk
What is being tested?: Watermelon, Beetroot and Watermelon + beetroot
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteBrazil
Study dates: 1 Mar 2021to 31 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;

Show all 9Show fewer

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal do Rio de Janeiro
Macaé, Rio de Janeiro, 27979-000

Other trials in Brazil

About this study

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

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
Being tested: Watermelon, Beetroot, Watermelon + beetroot, Placebo
Keywords: endothelial function, L-citrulline, nitrate, nitric oxide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WatermelonDietary supplement
A single dose of watermelon powder containing 3g of L-citrulline
BeetrootDietary supplement
A single dose of beetroot powder containing 8 mmol of nitrate
Watermelon + beetrootDietary supplement
A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate
PlaceboDietary supplement
A single dose of maltodextrin

Study groups in NCT04781595
Study group	Role	What they receive
Watermelon	Active comparator	Watermelon powder containing 3 g of L-citrulline. Receives: Dietary Supplement: Watermelon
Beetroot	Active comparator	Beetroot powder containing 8 mmol of nitrate. Receives: Dietary Supplement: Beetroot
Watermelon + beetroot	Active comparator	Watermelon powder containing 3 g of L-citrulline and Beetroot powder containing 8 mmol of nitrate. Receives: Dietary Supplement: Watermelon + beetroot
Placebo	Placebo comparator	Maltodextrin Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Flow-mediated dilation (FMD)
Measured: This measure will be evaluate before the nutritional intervention
Flow-mediated dilation (FMD)
Measured: This measure will be evaluate 60 minutes after the nutritional intervention
Flow-mediated dilation (FMD)
Measured: This measure will be evaluate 120 minutes after the nutritional intervention
Muscle oxygen saturation
Measured: This measure will be evaluate before the nutritional intervention
Muscle oxygen saturation
Measured: This measure will be evaluate 30 minutes after the nutritional intervention
Muscle oxygen saturation
Measured: This measure will be evaluate 60 minutes after the nutritional intervention
Muscle oxygen saturation
Measured: This measure will be evaluate 90 minutes after the nutritional intervention
Muscle oxygen saturation
Measured: This measure will be evaluate 120 minutes after the nutritional intervention

Secondary outcomes (15)

Plasmatic amino acids
Measured: This measure will be evaluate before the nutritional intervention
Plasmatic amino acids
Measured: This measure will be evaluate 30 minutes after the nutritional intervention
Plasmatic amino acids
Measured: This measure will be evaluate 60 minutes after the nutritional intervention
Plasmatic amino acids
Measured: This measure will be evaluate 90 minutes after the nutritional intervention
Plasmatic amino acids
Measured: This measure will be evaluate 120 minutes after the nutritional intervention
Plasmatic glucose
Measured: This measure will be evaluate before the nutritional intervention
Plasmatic glucose
Measured: This measure will be evaluate 30 min after the nutritional intervention
Plasmatic glucose
Measured: This measure will be evaluate 60 min after the nutritional intervention
Plasmatic glucose
Measured: This measure will be evaluate 90 min after the nutritional intervention
Plasmatic glucose
Measured: This measure will be evaluate 120 min after the nutritional intervention
Plasmatic insulin
Measured: This measure will be evaluate before the nutritional intervention
Plasmatic insulin
Measured: This measure will be evaluate 30 min after the nutritional intervention
Plasmatic insulin
Measured: This measure will be evaluate 60 min after the nutritional intervention
Plasmatic insulin
Measured: This measure will be evaluate 90 min after the nutritional intervention
Plasmatic insulin
Measured: This measure will be evaluate 120 min after the nutritional intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202131 Jul 2022

First posted4 Mar 2021
Study start1 Mar 2021
Primary completion30 Jun 2022
Study completion31 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy YoungStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04781595
Sponsor's protocol ID: E-26/202.905/2019
Status last verified: Dec 2022
First submitted: 23 Feb 2021
Last updated: 22 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37561087
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.
PubMed 36109652

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Watermelon and Beetroot Products on Endothelial Function in Young and Older Adults
ClinicalTrials.gov ID: NCT04781595
Acronym / sponsor ID: E-26/202.905/2019
Conditions: Healthy Young, Older People With Cardiovascular Disease Risk
Keywords: endothelial function, L-citrulline, nitrate, nitric oxide
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Universidade Federal do Rio de JaneiroUniversity, hospital or other
Study start: 1 Mar 2021 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 31 Jul 2022 (actual)
First posted: 4 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Watermelon	Active comparator	Dietary Supplement: WatermelonWatermelon powder containing 3 g of L-citrulline.
Beetroot	Active comparator	Dietary Supplement: BeetrootBeetroot powder containing 8 mmol of nitrate.
Watermelon + beetroot	Active comparator	Dietary Supplement: Watermelon + beetrootWatermelon powder containing 3 g of L-citrulline and Beetroot powder containing 8 mmol of nitrate.
Placebo	Placebo comparator	Dietary Supplement: PlaceboMaltodextrin

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WatermelonA single dose of watermelon powder containing 3g of L-citrulline	Dietary supplement	Watermelon
BeetrootA single dose of beetroot powder containing 8 mmol of nitrate	Dietary supplement	Beetroot
Watermelon + beetrootA single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate	Dietary supplement	Watermelon + beetroot
PlaceboA single dose of maltodextrin	Dietary supplement	Placebo

Primary outcome

Flow-mediated dilation (FMD)
Time frame: This measure will be evaluate before the nutritional intervention
Flow-mediated dilation (FMD)
Time frame: This measure will be evaluate 60 minutes after the nutritional intervention
Flow-mediated dilation (FMD)
Time frame: This measure will be evaluate 120 minutes after the nutritional intervention
Muscle oxygen saturation
Time frame: This measure will be evaluate before the nutritional intervention
Muscle oxygen saturation
Time frame: This measure will be evaluate 30 minutes after the nutritional intervention
Muscle oxygen saturation
Time frame: This measure will be evaluate 60 minutes after the nutritional intervention
Muscle oxygen saturation
Time frame: This measure will be evaluate 90 minutes after the nutritional intervention
Muscle oxygen saturation
Time frame: This measure will be evaluate 120 minutes after the nutritional intervention

15 secondary outcomes

Plasmatic amino acids
Time frame: This measure will be evaluate before the nutritional intervention
Plasmatic amino acids
Time frame: This measure will be evaluate 30 minutes after the nutritional intervention
Plasmatic amino acids
Time frame: This measure will be evaluate 60 minutes after the nutritional intervention
Plasmatic amino acids
Time frame: This measure will be evaluate 90 minutes after the nutritional intervention
Plasmatic amino acids
Time frame: This measure will be evaluate 120 minutes after the nutritional intervention
Plasmatic glucose
Time frame: This measure will be evaluate before the nutritional intervention
Plasmatic glucose
Time frame: This measure will be evaluate 30 min after the nutritional intervention
Plasmatic glucose
Time frame: This measure will be evaluate 60 min after the nutritional intervention
Plasmatic glucose
Time frame: This measure will be evaluate 90 min after the nutritional intervention
Plasmatic glucose
Time frame: This measure will be evaluate 120 min after the nutritional intervention
Plasmatic insulin
Time frame: This measure will be evaluate before the nutritional intervention
Plasmatic insulin
Time frame: This measure will be evaluate 30 min after the nutritional intervention
Plasmatic insulin
Time frame: This measure will be evaluate 60 min after the nutritional intervention
Plasmatic insulin
Time frame: This measure will be evaluate 90 min after the nutritional intervention
Plasmatic insulin
Time frame: This measure will be evaluate 120 min after the nutritional intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
Derived from this study: PubMed 37561087Volino-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.
Derived from this study: PubMed 36109652Volino-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thiago Alvares, PhD principal investigator

Universidade Federal do Rio de Janeiro

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flow-mediated dilation (FMD) (time frame: This measure will be evaluate before the nutritional intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04781595, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.