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HealthyNCT07192835

Effect of Fruit Elicitation With Melatonin on Human Health

A study testing Juice from melatonin-treated fruits in people with Healthy and Dietary Bioavailability, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

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

The goal of this clinical trial is to learn if treating fruits with melatonin helps the body absorb and use healthy plant compounds. It will also learn how much melatonin from the fruits is taken up by the body. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Dietary Bioavailability, Plant Extracts
What is being tested?
Juice from melatonin-treated fruits
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSpain
Study dates
1 Mar 2025to 1 Aug 2025
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults aged 18-65 years
  • Body mass index (BMI) between 18.5 and 24.9 kg/m²
  • Non-smokers
  • No chronic diseases (such as diabetes, cardiovascular disease, or cancer)
  • Not taking regular medication
  • Willing to follow a diet low in phenolic compounds and melatonin during the study periods
  • Able and willing to provide urine samples according to study instructions

Who cannot join

  • Presence of chronic diseases or metabolic disorders
  • Use of medications that could affect metabolism or absorption of compounds
  • Smoking or use of nicotine products
  • Allergies or intolerance to citrus fruits or cherries
  • Pregnancy or breastfeeding
  • Inability or unwillingness to comply with study procedures or dietary restrictions

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University Miguel Hernandez

    Orihuela, Alicante/Alacant, 03312

Other trials in Spain

About this study

The goal of this clinical trial is to learn if treating fruits with melatonin helps the body absorb and use healthy plant compounds. It will also learn how much melatonin from the fruits is taken up by the body. The main questions it aims to answer are:

  • Does melatonin treatment of fruits raise the amount of healthy compounds the body absorbs?
  • Does melatonin from treated fruits appear in urine after eating them?
Read more

Researchers will compare juice made from melatonin-treated fruits to juice made from untreated fruits to see if melatonin changes absorption.

Participants will:

  • Follow a special low-plant-compound diet for 3 days before each test day
  • Drink 300 grams of juice from treated or untreated fruit while fasting
  • Provide urine samples before and after drinking the juice
  • Return 15 days later to switch to the other juice type
  • Repeat this process with lemon, blood orange, and cherry
Read the detailed description

This clinical trial will investigate whether melatonin treatments in fruits can improve the bioavailability of bioactive compounds in humans. Melatonin is a natural molecule with antioxidant and protective properties. Its preharvest application has been shown to enhance postharvest fruit quality and raise the levels of phenolic compounds such as flavanones and anthocyanins. However, it is not yet known whether these changes in fruit composition result in greater absorption and metabolism of these compounds in humans after fruit consumption. The central hypothesis is that melatonin-treated fruits will show increased concentrations of bioactive compounds and melatonin, leading to higher bioavailability and urinary excretion of these compounds and their metabolites compared to untreated fruits. This would provide evidence that a sustainable agronomic practice can enhance not only fruit quality but also its nutritional and functional value for human health.

The study will follow a randomized acute crossover design with 20 healthy adult participants. Volunteers will consume juices prepared from melatonin-treated or untreated lemons, blood oranges, and sweet cherries under fasting conditions. Each participant will act as their own control, with a washout period of 15 days between interventions. To reduce variability, participants will follow a controlled low-phenolic and low-melatonin diet for three days before each test day. On the intervention day, urine samples will be collected before juice intake and at several time intervals over the following 24 hours (0-3.5 h, 3.5-12 h, and 12-24 h). Samples will be analyzed to determine the excretion of phenolic compounds, melatonin, and their metabolites, normalized by total urine volume. Fruits will be characterized using ultra-high-performance liquid chromatography coupled with triple quadrupole mass spectrometry (UHPLC-QqQ-MS/MS), and the same methodology will be applied to urine samples to provide precise and reliable quantification.

This project is of high scientific, social, and economic interest. From a scientific perspective, it will generate new knowledge about the bioavailability of bioactive compounds from melatonin-treated fruits, addressing a current gap in the understanding of how preharvest treatments influence not only fruit quality but also the absorption and metabolism of phenolics and melatonin in humans. These results may open new research avenues on the impact of sustainable agricultural strategies on human nutrition and health. From a social perspective, the study is aligned with increasing concerns about metabolic and cardiovascular diseases and with consumer demand for healthier foods. Understanding how to optimize the bioavailability of beneficial compounds through preharvest practices could promote dietary patterns that support better health. From an economic perspective, the trial focuses on fruits with Protected Geographical Indication (PGI), such as Valencian citrus and Alicante cherries. Demonstrating added nutritional and functional value through melatonin treatments could raise the competitiveness and market appeal of these products, supporting producers and the agro-food sector.

The feasibility of the study is guaranteed by access to the necessary resources and infrastructure. The fruits will be sourced from PGI-certified orchards in the Valencian Community, cultivated under conventional practices, and harvested at commercial maturity to ensure optimal quality. Melatonin treatments will be applied using manual sprayers at key stages of fruit development. The human intervention will take place at the Miguel Hernández University (UMH), where facilities are available to conduct the study and handle biological samples. Urine will be collected and stored at -80 °C until analysis to preserve sample integrity. The analytical laboratory is fully equipped with UHPLC and tandem mass spectrometry systems and has validated protocols for phenolic and melatonin analysis, developed in previous studies by the research team. The investigators have extensive experience in plant bioactives, fruit physiology, and human nutrition, ensuring proper execution of the project.

In summary, this study is innovative, multidisciplinary, and highly feasible. It will provide important insights at the intersection of agriculture, food science, and human health, with potential benefits for society, the scientific community, and the agro-food industry.

Being tested
Juice from untreated control fruits, Juice from melatonin-treated fruits
Keywords
Melatonin, Phenolic compounds, Flavanones, Anthocyanins, Lemon, Blood orange, Sweet cherry, Bioavailability, Human Nutrition, Functional Foods, Sustainable Agriculture

What participants receive

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

  • Juice from untreated control fruitsDietary supplement

    Participants will consume 300 g of juice prepared from untreated fruits (lemon, blood orange, or sweet cherry) under fasting conditions on the intervention day. Urine samples will be collected at 0-3.5 h, 3.5-12 h, and 12-24 h post-consumption to assess absorption and metabolism of bioactive compounds.

  • Juice from melatonin-treated fruitsDietary supplement

    Participants will consume 300 g of juice prepared from fruits (lemon, blood orange, or sweet cherry) treated preharvest with melatonin (0.1, 0.3, or 0.5 mM). Juice will be consumed under fasting conditions on the intervention day. Urine samples will be collected at 0-3.5 h, 3.5-12 h, and 12-24 h post-consumption to assess absorption and metabolism of bioactive compounds.

Study groups in NCT07192835
Study groupRoleWhat they receive
Melatonin-treated fruit first, then control fruitExperimentalParticipants will consume juice prepared from melatonin-treated fruits (lemon, blood orange, or sweet cherry) during the first intervention period, followed by juice from untreated control fruits after a 15-day washout period. Urine samples will be collected at specified intervals to measure bioactive compound absorption and metabolism.
Receives: Dietary Supplement: Juice from untreated control fruits; Dietary Supplement: Juice from melatonin-treated fruits
Control fruit first, then melatonin-treated fruitExperimentalParticipants will consume juice prepared from untreated control fruits (lemon, blood orange, or sweet cherry) during the first intervention period, followed by juice from melatonin-treated fruits after a 15-day washout period. Urine samples will be collected at specified intervals to measure bioactive compound absorption and metabolism.
Receives: Dietary Supplement: Juice from untreated control fruits; Dietary Supplement: Juice from melatonin-treated fruits

What is being measured

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

  1. Biodisponibility of phenolic compounds and melatonin from melatonin-treated fruits

    The primary outcome is the amount of phenolic compounds (flavanones and anthocyanins) and melatonin absorbed and excreted by participants after consuming 300 g of juice from melatonin-treated fruits. Urine samples are collected at 0-3.5 h, 3.5-12 h, and 12-24 h post-consumption, and concentrations are measured using UHPLC-QqQ-MS/MS. Excretion is normalized to creatinine to account for urine volume differences.

    Measured: 0-3.5, 3.5-12, and 12-24 hours post-consumption for each intervention period

Timeline

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

  1. First posted25 Sep 2025
  2. Study start1 Mar 2025
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
This is a randomized, acute, crossover study. Each participant will consume juice from both melatonin-treated fruits and untreated fruits in different periods, with a 15-day washout interval between interventions. All participants act as their own control, allowing direct comparison of bioactive compound absorption and metabolism between treated and untreated fruits. The order of interventions will be randomized to minimize sequence effects.
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07192835
Sponsor's protocol ID
DTA.VAG.240905
Status last verified
Sep 2025
First submitted
17 Sep 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agullo V, Villano D, Garcia-Viguera C, Dominguez-Perles R. Anthocyanin Metabolites in Human Urine after the Intake of New Functional Beverages. Molecules. 2020 Jan 16;25(2):371. doi: 10.3390/molecules25020371.

    PubMed 31963236
  • Agullo V, Dominguez-Perles R, Moreno DA, Zafrilla P, Garcia-Viguera C. Alternative Sweeteners Modify the Urinary Excretion of Flavanones Metabolites Ingested through a New Maqui-Berry Beverage. Foods. 2020 Jan 3;9(1):41. doi: 10.3390/foods9010041.

    PubMed 31947712

Questions about this trial

What is this clinical trial studying?

A study testing Juice from melatonin-treated fruits in people with Healthy and Dietary Bioavailability, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

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 7 inclusion and 6 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 25 Sep 2025. 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 Spain. 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. 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?

Biodisponibility of phenolic compounds and melatonin from melatonin-treated fruits (time frame: 0-3.5, 3.5-12, and 12-24 hours post-consumption for each intervention period). 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 NCT07192835, 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 25 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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