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Trial record 48 of 727 for:    Area Under Curve AND Bioavailability

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
Sponsor:
Collaborators:
Eurecat
Hospital Universitari Sant Joan de Reus
Plantas Medicinales y Complementos Alimenticios (PLAMECA), S.A.
University Rovira i Virgili
Information provided by (Responsible Party):
Technological Centre of Nutrition and Health, Spain

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women over 18 years of age.
  2. Firm the informed consent.

Exclusion Criteria:

  1. 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.
  2. Present intolerances and / or food allergies related to melatonin.
  3. Presenting anemia (hemoglobin ≤ 13 g/dL in men and ≤ 12 g/dL in women).
  4. Being pregnant or intending to become pregnant.
  5. Be in breastfeeding period.
  6. Be a smoker
  7. Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.

Information from the National Library of Medicine

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


Contacts
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Contact: Rosa M Valls, PhD 0034 636944723 estudis@ctns.cat
Contact: Anna Crescenti, PhD +34977770958 anna.crescenti@eurecat.org

Locations
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Spain
Centro Tecnológico de Nutrición y Salud (Eurecat-Reus) Not yet recruiting
Reus, Tarragona, Spain
Contact: Rosa M Valls, PhD    +34 636 944 723    estudis@ctns.cat   
Contact: Anna Crescenti, PhD    +34 977 77 09 58    anna.crescenti@eurecat.org   
Sponsors and Collaborators
Technological Centre of Nutrition and Health, Spain
Eurecat
Hospital Universitari Sant Joan de Reus
Plantas Medicinales y Complementos Alimenticios (PLAMECA), S.A.
University Rovira i Virgili
Investigators
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Principal Investigator: Rosa Solà, Dr Centro Tecnológico de Nutrición y Salud (Eurecat_Reus). Reus, Tarragona, Spain.

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Responsible Party: Technological Centre of Nutrition and Health, Spain
ClinicalTrials.gov Identifier: NCT03951025     History of Changes
Other Study ID Numbers: MELATONIN
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Technological Centre of Nutrition and Health, Spain:
melatonin
oral administration
sublingual administration
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants