Oral Bioavailability of the Phenolic Compounds in a Melissa Supplement

NCT06949592 | Completed

• 1 other identifier: BIOLEMON
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to identify phenolic compound biomarkers of the intake of a mixture of Melissa officinalis extract, acerola extract and vitamin B5. This will be done through the study of their bioavailability and nutrikinetics by measuring their plasma concentrations and urinary excretion over 24h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects

Conditions

Nutrition, Healthy

Outcome Measures

Primary Outcomes (1)

• Changes in plasma concentrations of phenolic metabolites after acute ingestion of the supplement/placebo

  Plasma samples will be collected in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Concentrations will be analyzed using liquid chromatography-time of light-mass spectometry (LC-qToF-MS). Results will be reported in nanomolar (nM).

  At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.

Secondary Outcomes (17)

• Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo

  At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.

• Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo

  At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.

• Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo

  At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.

• Change in plasma half-life (T1/2) of phenolic metabolites after acute ingestion of the supplement/placebo

  At baseline and at 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, and 24 hour after treatment intake.

• Changes in 24h cumulative urinary excretion of phenolic metabolites after acute ingestion of the supplement/placebo

  At baseline and at 3 hour, 6 hour, 10 hour and 24 hour after treatment intake.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

This arm receives 400 mg maltodextrin

Dietary Supplement: Placebo

M_ML

EXPERIMENTAL

This arm receives 400 mg of M\_ML. M\_ML is a mixture of a polyphenol-rich Melissa officinalis extract, an acerola extract and vitamin B5.

Dietary Supplement: M_ML

Interventions

Placebo DIETARY_SUPPLEMENT

Intake of 400 mg placebo (maltodextrin; encapsulated) in the morning (09:00)

Placebo

M_ML DIETARY_SUPPLEMENT

Intake of 400 mg M\_ML (encapsulated) in the morning (09:00)

M_ML

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between 18 and 60 years old.
• Agree to follow the dietary and exercise guidelines of the study.
• Sign the informed consent form.
• Be able to read, write, and speak Spanish and/or Catalan.

You may not qualify if:

• Body Mass Index (BMI) \<18.5 kg/m² or ≥30 kg/m².
• Presence of intolerances or allergies related to polyphenols or any of the components of the products evaluated, such as acerola, maltodextrin, or Melissa officinalis.
• Use of medication that could affect the study results, including antibiotics, glucocorticoids, steroids, antidepressants (especially selective serotonin reuptake inhibitors (SSRIs), medications used to control sleep or stress, antipsychotics, anticonvulsants, oral contraceptives, beta-blockers, benzodiazepines, and antihypertensives.
• Regular consumption herbal or plant-based supplements. Participants who take multivitamin supplements may still participate in the study, provided they agree to stop taking them for 48 hours before and on the day of the intervention.
• Regular consumption of melatonin supplements. Participants who occasionally take melatonin may be included if they have had at least a one-week washout period since the last dose.
• Presence of disrupted sleep cycle or irregular sleep routines, such as shift workers (night or rotating shifts), or due to external factors such as recent or upcoming travel across time zones, or co-sleeping with a newborn/baby that disrupts sleep.
• Report self-perceived psychological stress, meaning they answer "yes" to the question: "Do you consider yourself to be severely stressed?"
• Self-reported trouble sleeping and/or falling asleep.
• To be diagnosed with anemia.
• Active smoker or have quit smoking less than 6 months ago.
• Consumption of alcoholic beverages: Men: 4 or more Standard Drink Units (SDUs)\* daily or 28 SDUs weekly; Women: 2 or more SDUs daily or 17 SDUs weekly.
• Presence of liver, kidney, or gastrointestinal disease that may affect compound absorption and/or study results, such as: celiac disease, Crohn's disease, chronic kidney disease, active cancer in any digestive or renal organ, or hepatitis.
• Have lost 3 kg or more in the past 3 months.
• Pregnant or planning to become pregnant.
• Currently breastfeeding.

Sponsors & Collaborators

• Fytexia: lead

Study Sites (1)

Eurecat

Reus, Tarragona, 43204, Spain

Location

Study Officials

• Antoni Caimari Palou, PhD

  Fundació Eurecat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 29, 2025
• Study Start: April 30, 2025
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)