Oral Bioavailability of the Phenolic Compounds in a Melis... | NCT06949592

NCT06949592

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Dietary Supplement	Intake of 400 mg placebo (maltodextrin; encapsulated) in the morning (09:00)	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in plasma area under the curve (AUC) 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 LC-qToF-MS.	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.

Eligibility Module

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).