Effect of a Novel Melatonin Supplement on Sleep Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-04

Study Completion Date

2024-04-18

Brief Summary

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Melatonin is a hormone naturally found in our body that increases in our blood at night and controls how we sleep. Melatonin can also be taken as a pill and numerous clinical trials have documented improved sleep quality following melatonin supplementation before bed. However, it is not known whether such supplements actually increase blood melatonin above normal levels, particularly at night.

The aims of this study are to investigate whether a novel melatonin supplement (Ritual Sleep BioSeriesTM Melatonin) can increase blood melatonin in human participants at night, and to determine if taking the supplement before bed for two-weeks can improve sleep quality.

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Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised cross over trial counterbalanced for trial order

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Coded, known only to manufacturer / collaborator

Study Groups

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Melatonin supplementation

5mg melatonin supplement from Ritual Inc's BioSeries

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

5mg melatonin supplement, once daily, from Ritual BioSeries

Placebo supplementation

Placebo supplement from Ritual Inc.

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement, once daily, from Ritual BioSeries

Interventions

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Melatonin

5mg melatonin supplement, once daily, from Ritual BioSeries

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Placebo supplement, once daily, from Ritual BioSeries

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Aged 18-40
* Sometimes have trouble sleeping (Pittsburgh sleep quality index score \>5)

Exclusion Criteria

* Routinely taking melatonin supplements or other drugs known to affect sleep
* A diagnosed sleep disorder
* Major psychiatric illness
* Current physical injury
* Known or suspected hypersensitivity to melatonin
* Presence of major sleep disruptors at home (e.g. new born baby)
* Night shift/rotational-shift work
* Receiving non-pharmacological treatment for sleep disorder (e.g. cognitive behavioral therapy)
* Substance use disorder
* Recent (\<1 month) increase in daily caffeinated drink consumption
* Consuming \>14 standard alcoholic drinks per week
* Pregnant or lactating

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes