Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN) (MELATONIN)
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|ClinicalTrials.gov Identifier: NCT03951025|
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sleep disorders represent an important public health problem that cause important personal problems, absenteeism and considerable health costs. Although the main drugs used for the treatment of insomnia are still Benzodiazepines and Z-drugs (Zolpidem, Zopiclone, Zaleplon), these are not entirely effective and have numerous side effects that lead to poor compliance with therapy . For the treatment of sleep disorders, alternative non-pharmacological therapies have also been implemented, such as cognitive therapy, relaxation therapy, and the introduction of new agents, including the use of melatonin as a human endogenous molecule with low or zero toxicity.
In Europe, the European Food Safety Authority (EFSA) has stated that "A cause and effect relationship is established between the consumption of melatonin and the alleviation of subjective feelings of jet lag. In order to present the declaration of health, the dose of melatonin should be between 0.5 and 5 mg and should be taken close to bedtime on the first day (and subsequent days) of the trip and the following days after arrival at destination.The target population is the general population ". On the other hand, the EFSA states that "A cause and effect relationship is established between the consumption of melatonin and the reduction of sleep onset latency. The Panel considers that to obtain the declared effect, 1 mg of melatonin should be consumed near bedtime. The target population is the general population."
The results of several studies in humans show that melatonin administered orally has a low bioavailability (approximately percentage) and a very short half-life. Therefore, it has been suggested that the sublingual route represents an attractive alternative for the administration of compounds that have a low bioavailability, since through this route, the substances are distributed throughout the body avoiding the loss of the compounds by their first-pass metabolism by the liver, as well as the loss by the process of absorption by the digestive system.
On this basis the present hypothesis is posed: the administration of melatonin sublingually will have a greater bioavailability than the administration of melatonin orally.
The main objective of this study was to quantify the bioavailability of 1 mg of melatonin when administered sublingually and orally.
|Condition or disease||Intervention/treatment||Phase|
|Biological Availability||Dietary Supplement: Melatonin oral administration Dietary Supplement: Melatonin sublingual administration||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually Compared to Its Oral Administration. Randomized, Crossover, Single-blind Study|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: Melatonin oral administration
Consumption of one tablet with 1 mg of melatonin orally
Dietary Supplement: Melatonin oral administration
One tablet with1 mg of melatonin and 82 mg of excipients
Experimental: Melatonin sublingual administration
Consumption of one tablet with 1 mg of melatonin sublingually
Dietary Supplement: Melatonin sublingual administration
One tablet with 1 mg of melatonin and 82 mg of excipients
- Bioavailability of melatonin calculated by the Area Under The Curve (AUC) [ Time Frame: At week 1 and week 2. The extraction and bleeding points of melatonin will be at basal time, before taking the tablet and at 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours and 6 hours after tablet intake. ]
Fasting melatonin blood levels will be determined before consuming the melatonin supplement until 6 hours postprandially at 7 points after consuming the melatonin supplement.
The melatonin levels in plasma will be quantified with a Liquid Chromathography (LC)-(ESI+)- Mass Spectrometry (MS)/MS from their pure commercial standard using melatonin-d4 as internal standard.
- Maximum plasma concentration (Cmax) [ Time Frame: At week 1 and week 2. The extraction and bleeding points of melatonin will be at basal time, before taking the tablet and at 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours and 6 hours after tablet intake. ]Maximum plasma concentration of melatonin. Cmax will be measured by pharmacokinetics formulas from the melatonin values measured at different times (basal and postprandial)
- Time for maximum plasma concentration (Tmax) [ Time Frame: At week 1 and week 2. The extraction and bleeding points of melatonin will be at basal time, before taking the tablet and at 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours and 6 hours after tablet intake. ]Time period for the maximum plasma concentration of melatonin.
- Half-life (T1/2) [ Time Frame: At week 1 and week 2. The extraction and bleeding points of melatonin will be at basal time, before taking the tablet and at 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours and 6 hours after tablet intake. ]Time taken for half the initial dose of melatonin administered to be eliminated from the body
- Melatonin urine levels [ Time Frame: At week 1 and week 2. Urine at basal time and at 3 hours and 6 hours after tablet consumption. ]Determination of melatonin and/or its main metabolite 6-sulfatoxymelatonin in urine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951025
|Contact: Rosa M Valls, PhD||0034 email@example.com|
|Contact: Anna Crescenti, PhDfirstname.lastname@example.org|
|Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)||Not yet recruiting|
|Reus, Tarragona, Spain|
|Contact: Rosa M Valls, PhD +34 636 944 723 email@example.com|
|Contact: Anna Crescenti, PhD +34 977 77 09 58 firstname.lastname@example.org|
|Principal Investigator:||Rosa Solà, Dr||Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.|