BioavailabilityMELFENILNCT05835258
Oral Bioavailability of Two Melatonin Supplements
A study testing Melatonin with phenyl capsaicin and Melatonin without phenyl capsaicin in people with Bioavailability, run by Fundació Eurecat at 1 site in Spain.
Trial summary
Results from several clinical studies show that orally administered melatonin has low bioavailability and a very short half-life. Phenyl capsaicin, a synthetic analogue of capsaicin, might increase its bioavailability by inhibiting the enzymes involved in its hepatic metabolism. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Melatonin with phenyl capsaicin and Melatonin without phenyl capsaicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2023to 14 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 65 years old.
- Sign the informed consent form.
- Know how to read, write and speak Catalan or Spanish.
Who cannot join
- Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study (e.g. L-Tryptophan or melatonin)
- Present intolerances and/or food allergies related to melatonin, phenyl capsaicin, microcrystalline cellulose or silicon dioxide .
- Be a smoker.
- Having received antibiotic treatment up to 30 days before the start of the study.
- Present values of body mass index ≤ 18kg/m^2 or ≥ 35 kg/m^2.
- Present some chronic disease with clinical manifestations: coronary heart disease, cardiovascular disease, diabetes mellitus, hypertension, ulcerative colitis, celiac disease, Crohn's disease, chronic kidney disease, cancer, benign prostatic hyperplasia, autoimmune diseases (such as fibromyalgia), respiratory and/or gastrointestinal diseases that may compromise the absorption of the compound.
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- Clinical history of anemia.
- Being pregnant or intending to became pregnant.
- Be in breastfeeding period.
- Being unable to follow the study guidelines.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days before inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study for the Comparison of the Oral Bioavailability of Two Melatonin Supplements
Results from several clinical studies show that orally administered melatonin has low bioavailability and a very short half-life. Phenyl capsaicin, a synthetic analogue of capsaicin, might increase its bioavailability by inhibiting the enzymes involved in its hepatic metabolism.
Thus, the hypothesis of the present study is that the administration of melatonin supplement with phenyl capsaicin presents greater bioavailability than a melatonin supplement that does not contain phenyl capsaicin.
Read the detailed description
Melatonin is an endogenous indolamine that regulates many physiological functions such as reproduction, temperature, mood, bone growth or the immune system. However, since its production is closely related to the light/dark cycle, melatonin is considered one of the main chronobiotic agents that modulates circadian rhythms.
For this reason, in recent years there has been increased interest in the exogenous use of melatonin to address problems of insomnia and circadian rhythm disorders such as jet lag syndrome or shift work. Although many studies have demonstrated the effectiveness of melatonin in treating sleep disorders, pharmacokinetic studies show that it has poor oral bioavailability and a very short half-life. So, new strategies and studies are necessary to increase the low bioavailability of melatonin.
In this context, it has been shown that phenyl capsaicin, a synthetic analogue of capsaicin, might increase melatonin's bioavailability by inhibiting Cytochrome P450 liver enzymes, which are involved in its metabolism. Therefore, the main objective of this study is to quantify and compare the oral bioavailability between a melatonin supplement with phenyl capsaicin and another melatonin supplement that does not contain phenyl capsaicin.
The secondary objectives of the study are to determine the pharmacokinetic parameters:
- Maximum plasma concentration (Cmax).
- Time for maximum plasma concentration (Tmax).
- Half-life (T1/2).
- Area Under the Curve (AUC 0-inf) of plasma melatonin levels
During the study there will be 3 visits: a preselection visit (V0), a visit for the first postprandial study (V1) and after one week washing period, a visit for the second postprandial study (V2).
- Conditions
- Bioavailability
- Being tested
- Melatonin with phenyl capsaicin, Melatonin without phenyl capsaicin
- Keywords
- Melatonin, Phenyl capsaicin, Bioenhancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin with phenyl capsaicinDietary supplement
Blood samples will be collected at different time points following the oral administration of the melatonin supplement with phenyl capsaicin
Melatonin without phenyl capsaicinDietary supplement
Blood samples will be collected at different time points following the oral administration of the melatonin supplement without phenyl capsaicin
| Study group | Role | What they receive |
|---|---|---|
| Melatonin with phenyl capsaicin | Experimental | Participants will consume one capsule of 1 mg of melatonin with phenyl capsaicin Receives: Dietary Supplement: Melatonin with phenyl capsaicin |
| Melatonin without phenyl capsaicin | Active comparator | Participants will consume one capsule of 1 mg of melatonin without phenyl capsaicin Receives: Dietary Supplement: Melatonin without phenyl capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of melatonin calculated by the Area Under The Curve (AUC 0-6) of plasma melatonin levels
Fasting melatonin levels in plasma will be determined before consuming the melatonin supplement until 6 hours postprandially at 7 points after consuming the capsule (15 min., 30 min., 45 min., 1h., 2h., 4h and 6h).
The melatonin levels in plasma will be quantified by Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS)
Measured: At week 1
Bioavailability of melatonin calculated by the Area Under The Curve (AUC 0-6) of plasma melatonin levels
Fasting melatonin levels in plasma will be determined before consuming the melatonin supplement until 6 hours postprandially at 7 points after consuming the capsule (15 min., 30 min., 45 min., 1h., 2h., 4h and 6h).
The melatonin levels in plasma will be quantified by Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS)
Measured: At week 3
Secondary outcomes (8)
Maximum plasma concentration (Cmax)
Maximum plasma concentration of melatonin
Measured: At week 1
Maximum plasma concentration (Cmax)
Maximum plasma concentration of melatonin
Measured: At week 3
Time for maximum plasma concentration (Tmax)
Time period for the maximum plasma concentration of melatonin
Measured: At week 1
Time for maximum plasma concentration (Tmax)
Time period for the maximum plasma concentration of melatonin
Measured: At week 3
Half-life (T1/2)
Time taken for half the initial dose of melatonin administered to be eliminated from the body
Measured: At week 1
Half-life (T1/2)
Time taken for half the initial dose of melatonin administered to be eliminated from the body
Measured: At week 3
Area Under the Curve (AUC 0-inf) to infinite time of plasma melatonin levels
AUC 0-inf extrapolates the area to infinite time and measures the total melatonin exposure across time.
Measured: At week 1
Area Under the Curve (AUC 0-inf) to infinite time of plasma melatonin levels
AUC 0-inf extrapolates the area to infinite time and measures the total melatonin exposure across time.
Measured: At week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start30 May 2023
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover, Randomized, Triple-Blind Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Collaborators
- URIACH, S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835258
- Sponsor's protocol ID
- MELFENIL
- Acronym
- MELFENIL
- Status last verified
- Jul 2023
- First submitted
- 18 Apr 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study for the Comparison of the Oral Bioavailability of Two Melatonin Supplements
- ClinicalTrials.gov ID
- NCT05835258
- Acronym / sponsor ID
- MELFENIL / MELFENIL
- Conditions
- Bioavailability
- Keywords
- Melatonin, Phenyl capsaicin, Bioenhancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Collaborators
- URIACH, S.L.
- Study start
- 30 May 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Results from several clinical studies show that orally administered melatonin has low bioavailability and a very short half-life. Phenyl capsaicin, a synthetic analogue of capsaicin, might increase its bioavailability by inhibiting the enzymes involved in its hepatic metabolism.
Thus, the hypothesis of the present study is that the administration of melatonin supplement with phenyl capsaicin presents greater bioavailability than a melatonin supplement that does not contain phenyl capsaicin.
Detailed description
Melatonin is an endogenous indolamine that regulates many physiological functions such as reproduction, temperature, mood, bone growth or the immune system. However, since its production is closely related to the light/dark cycle, melatonin is considered one of the main chronobiotic agents that modulates circadian rhythms.
For this reason, in recent years there has been increased interest in the exogenous use of melatonin to address problems of insomnia and circadian rhythm disorders such as jet lag syndrome or shift work. Although many studies have demonstrated the effectiveness of melatonin in treating sleep disorders, pharmacokinetic studies show that it has poor oral bioavailability and a very short half-life. So, new strategies and studies are necessary to increase the low bioavailability of melatonin.
In this context, it has been shown that phenyl capsaicin, a synthetic analogue of capsaicin, might increase melatonin's bioavailability by inhibiting Cytochrome P450 liver enzymes, which are involved in its metabolism. Therefore, the main objective of this study is to quantify and compare the oral bioavailability between a melatonin supplement with phenyl capsaicin and another melatonin supplement that does not contain phenyl capsaicin.
The secondary objectives of the study are to determine the pharmacokinetic parameters:
- Maximum plasma concentration (Cmax).
- Time for maximum plasma concentration (Tmax).
- Half-life (T1/2).
- Area Under the Curve (AUC 0-inf) of plasma melatonin levels
During the study there will be 3 visits: a preselection visit (V0), a visit for the first postprandial study (V1) and after one week washing period, a visit for the second postprandial study (V2).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover, Randomized, Triple-Blind Study
| Arm | Type | Receives |
|---|---|---|
| Melatonin with phenyl capsaicin | Experimental | Dietary Supplement: Melatonin with phenyl capsaicinParticipants will consume one capsule of 1 mg of melatonin with phenyl capsaicin |
| Melatonin without phenyl capsaicin | Active comparator | Dietary Supplement: Melatonin without phenyl capsaicinParticipants will consume one capsule of 1 mg of melatonin without phenyl capsaicin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women between 18 and 65 years old.
- Sign the informed consent form.
- Know how to read, write and speak Catalan or Spanish.
Key exclusion criteria (11 listed)
- Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study (e.g. L-Tryptophan or melatonin)
- Present intolerances and/or food allergies related to melatonin, phenyl capsaicin, microcrystalline cellulose or silicon dioxide .
- Be a smoker.
- Having received antibiotic treatment up to 30 days before the start of the study.
- Present values of body mass index ≤ 18kg/m^2 or ≥ 35 kg/m^2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin with phenyl capsaicinBlood samples will be collected at different time points following the oral administration of the melatonin supplement with phenyl capsaicin | Dietary supplement | Melatonin with phenyl capsaicin |
| Melatonin without phenyl capsaicinBlood samples will be collected at different time points following the oral administration of the melatonin supplement without phenyl capsaicin | Dietary supplement | Melatonin without phenyl capsaicin |
Primary outcome
Bioavailability of melatonin calculated by the Area Under The Curve (AUC 0-6) of plasma melatonin levels
Time frame: At week 1
Fasting melatonin levels in plasma will be determined before consuming the melatonin supplement until 6 hours postprandially at 7 points after consuming the capsule (15 min., 30 min., 45 min., 1h., 2h., 4h and 6h). The melatonin levels in plasma will be quantified by Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS)
Bioavailability of melatonin calculated by the Area Under The Curve (AUC 0-6) of plasma melatonin levels
Time frame: At week 3
Fasting melatonin levels in plasma will be determined before consuming the melatonin supplement until 6 hours postprandially at 7 points after consuming the capsule (15 min., 30 min., 45 min., 1h., 2h., 4h and 6h). The melatonin levels in plasma will be quantified by Liquid Chromatography coupled with Tandem Mass Spectrometry (LC-MS/MS)
8 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: At week 1
Maximum plasma concentration (Cmax)
Time frame: At week 3
Time for maximum plasma concentration (Tmax)
Time frame: At week 1
Time for maximum plasma concentration (Tmax)
Time frame: At week 3
Half-life (T1/2)
Time frame: At week 1
Half-life (T1/2)
Time frame: At week 3
Area Under the Curve (AUC 0-inf) to infinite time of plasma melatonin levels
Time frame: At week 1
Area Under the Curve (AUC 0-inf) to infinite time of plasma melatonin levels
Time frame: At week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Technological Centre of Nutrition and Health. Eurecat\_Reus.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin with phenyl capsaicin and Melatonin without phenyl capsaicin in people with Bioavailability, run by Fundació Eurecat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of melatonin calculated by the Area Under The Curve (AUC 0-6) of plasma melatonin levels (time frame: At week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.