Effect of a Novel Melatonin Supplement on Sleep Quality (I-MASQ)

University of Exeter

Status: Completed

Conditions: Sleep

Treatments: Dietary Supplement: Melatonin; Dietary Supplement: Placebo supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06215573

WT4634027_I-MASQ v2.0

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Melatonin supplementation

Experimental group

Description:

5mg melatonin supplement from Ritual Inc's BioSeries

Treatment:

Dietary Supplement: Melatonin

Placebo supplementation

Placebo Comparator group

Description:

Placebo supplement from Ritual Inc.

Treatment:

Dietary Supplement: Placebo supplement