Effect of Fruit Elicitation With Melatonin on Human Health

NCT07192835 | Completed

• 1 other identifier: DTA.VAG.240905
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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? 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

Conditions

Healthy; Dietary Bioavailability; Plant Extracts; Phenolic Compounds; Melatonin

Keywords

Melatonin; Phenolic compounds; Flavanones; Anthocyanins; Lemon; Blood orange; Sweet cherry; Bioavailability; Human Nutrition; Functional Foods; Sustainable Agriculture

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

Melatonin-treated fruit first, then control fruit

EXPERIMENTAL

Participants 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.

Dietary Supplement: Juice from untreated control fruits; Dietary Supplement: Juice from melatonin-treated fruits

Control fruit first, then melatonin-treated fruit

EXPERIMENTAL

Participants 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.

Dietary Supplement: Juice from untreated control fruits; Dietary Supplement: Juice from melatonin-treated fruits

Interventions

Juice from untreated control fruits DIETARY_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.

Control fruit first, then melatonin-treated fruit; Melatonin-treated fruit first, then control fruit

Juice from melatonin-treated fruits DIETARY_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.

Control fruit first, then melatonin-treated fruit; Melatonin-treated fruit first, then control fruit

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• National Research Council, Spain: collaborator

Study Sites (1)

University Miguel Hernandez

Orihuela, Alicante/Alacant, 03312, Spain

Location

Related Publications (2)

• 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.

  PMID: 31963236 BACKGROUND

• 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.

  PMID: 31947712 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)