Examining how well phenolic compounds from a Melissa supplement are absorbed in the body

Evaluation of Oral Bioavailability of the Phenolic Compounds in a Melissa Supplement: Double-blind, Randomized, Crossover Study

This study is testing how well the body absorbs a supplement made from lemon balm, acerola, and vitamin B5 to see if it can be beneficial for healthy people.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Fytexia (industry)
• Locations: 1 site (Reus, Tarragona)
• Trial ID: NCT06949592 on ClinicalTrials.gov

What this trial studies

This study aims to identify biomarkers for the intake of a mixture of Melissa officinalis extract, acerola extract, and vitamin B5 by measuring their bioavailability and nutrikinetics. It employs a cross-over, double-blind, randomized, and placebo-controlled design involving 10 healthy subjects. The researchers will analyze plasma concentrations and urinary excretion of the compounds over a 24-hour period using high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS).

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18 to 60 who can adhere to dietary and exercise guidelines.

Not a fit: Patients with a BMI outside the range of 18.5 to 30 kg/m² or those with allergies to the study components may not benefit.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how these compounds are absorbed, potentially leading to improved dietary supplements.

How similar studies have performed: While similar studies on bioavailability of dietary supplements exist, this specific combination of compounds is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Previous blood extraction and/or donation: ≥200 ml within 1 month prior to study inclusion, or ≥400 ml within 3 months prior to study inclusion.
* Have lost 3 kg or more in the past 3 months.
* Pregnant or planning to become pregnant.
* Currently breastfeeding.
* Unable to comply with the study protocol.
* Currently participating or have participated in a nutritional intervention study involving nutraceuticals or pharmaceuticals within the 30 days prior to inclusion in this study.
* Deemed unsuitable to participate in the study according to the judgment of the evaluator conducting the pre-selection.

One SDU is defined as the average alcohol content of a standard drink in terms of alcohol strength and volume. One SDU is approximately 10 grams of alcohol, which equals:1 glass of wine (120 ml), 1 beer (330 ml), 1 small liquor (25 ml); 2 SDUs equal: 1 glass of cognac or liqueur (55 ml),1 whisky (70 ml),1 mixed drink (75 ml).

Where this trial is running

Reus, Tarragona

• Eurecat — Reus, Tarragona, Spain (RECRUITING)

Study contacts

• Principal investigator: Antoni Caimari Palou, PhD — Fundació Eurecat
• Study coordinator: Julien Cases, PhD

Conditions: Nutrition, Healthy