Oral Bioavailability of the Phenolic Compounds in a Melissa Supplement (BIOLEMON)

Fytexia

Status: Completed

Conditions: Nutrition, Healthy

Treatments: Dietary Supplement: M_ML; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06949592

BIOLEMON

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

This arm receives 400 mg maltodextrin

Treatment:

Dietary Supplement: Placebo

M_ML

Experimental group

Description:

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.

Treatment:

Dietary Supplement: M_ML

Dietary Supplement: M_ML