Oral Bioavailability of Two Melatonin Supplements

NCT05835258 | Completed

• 1 other identifier: MELFENIL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bioavailability

Keywords

Melatonin; Phenyl capsaicin; Bioenhancer

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  At week 3

Secondary Outcomes (8)

• Maximum plasma concentration (Cmax)

  At week 1

• Maximum plasma concentration (Cmax)

  At week 3

• Time for maximum plasma concentration (Tmax)

  At week 1

• Time for maximum plasma concentration (Tmax)

  At week 3

• Half-life (T1/2)

  At week 1

Study Arms (2)

Melatonin with phenyl capsaicin

EXPERIMENTAL

Participants will consume one capsule of 1 mg of melatonin with phenyl capsaicin

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

Dietary Supplement: Melatonin without phenyl capsaicin

Interventions

Melatonin with phenyl capsaicin DIETARY_SUPPLEMENT

Blood samples will be collected at different time points following the oral administration of the melatonin supplement with phenyl capsaicin

Melatonin with phenyl capsaicin

Melatonin without phenyl capsaicin DIETARY_SUPPLEMENT

Blood samples will be collected at different time points following the oral administration of the melatonin supplement without phenyl capsaicin

Melatonin without phenyl capsaicin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 18 and 65 years old.
• Sign the informed consent form.
• Know how to read, write and speak Catalan or Spanish.

You may not qualify if:

• 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.
• Clinical history of anemia.
• Being pregnant or intending to became pregnant.
• Be in breastfeeding period.
• Being unable to follow the study guidelines.

Sponsors & Collaborators

• Fundació Eurecat: lead
• URIACH, S.L.: collaborator

Study Sites (1)

Eurecat

Reus, 43204, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover, Randomized, Triple-Blind Study

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: May 30, 2023
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)