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Effects of a Novel Supplement on Sleep, Metabolism, Body Composition and Performance

NCT05236504 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-04-01

No results posted yet for this study

Summary

This study aimed to investigate the effects of a novel dietary supplement, consisting of melatonin and magnesium in a pod (coffee machine capsule) format, on sleep quality, stress, mood, sleepiness, biological rhythms, metabolism, body composition and performance, in individuals with sleep disturbances according with the Pittsburgh Sleep Quality Index. A randomized, double-blind, crossover trial will be conducted to compare the effects of the melatonin and magnesium-containing supplement against a placebo. The protocol comprises 4 weeks of supplementation with an experimental or placebo condition, with a week-long washout period. Biochemical markers of sleep and stress, actigraphy for sleep patterns and sleep hygiene, resting metabolic rate, food and fluid intake, body composition, and handgrip strength measures will be evaluated at baseline and 4 weeks post each randomly assigned intervention. The working hypothesis is that this innovative supplement will provide greater objective and subjective improvements regarding sleep patterns and quality, overall mood, biochemical markers of stress, resting metabolic rate, energy intake, body composition and strength, than the placebo comparator, due to the synergic effects of melatonin and magnesium.

Conditions

  • Sleep Hygiene
  • Sleep Disturbance

Interventions

DIETARY_SUPPLEMENT

Melatonin and magnesium-containing pod

A 50-100mL hot water drink, obtained from a coffee pod machine, containing 1.9mg of melatonin and 200mg of magnesium in a powdered form, will be ingested 30 minutes before bedtime. Total duration of this intervention: 4 weeks, after which 1 week of washout will occur, before switching to the other intervention.

OTHER

Placebo comparator

A 50-100mL hot water drink of identical taste, obtained from an identical pod with the same ingredients except melatonin and magnesium, will be ingested 30 minutes before bedtime. Total duration of this intervention: 4 weeks, after which 1 week of washout will occur, before switching to the other intervention.

Sponsors & Collaborators

  • Bettery S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-28
Primary Completion
2022-06-30
Completion
2022-07-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236504 on ClinicalTrials.gov