Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT06949592
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06949592
Study Brief:
Protocol Section:
NCT06949592