NCT05236504 (4BETTSLEEP) is a NA clinical trial of Melatonin and magnesium-containing pod in Sleep Hygiene, sponsored by Bettery S.A..

Who is sponsoring NCT05236504?

NCT05236504 is sponsored by Bettery S.A..

What drugs are being tested in NCT05236504?

Interventions in NCT05236504: Melatonin and magnesium-containing pod, Placebo comparator.

What condition does NCT05236504 study?

NCT05236504 studies Sleep Hygiene, Sleep Disturbance.

Is NCT05236504 still recruiting?

NCT05236504 is currently status unknown. Last updated 1 April 2022.

Last reviewed 2022-04-01 · How we verify

NCT05236504: 4BETTSLEEP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown NA Last updated 1 April 2022

What this trial tests

NA trial testing Melatonin and magnesium-containing pod in Sleep Hygiene in 35 participants. Status unknown.

Timeline

28 November 2021

Primary endpoint
30 June 2022

30 July 2022

Quick facts

Lead sponsor	Bettery S.A.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	35
Start date	28 November 2021
Primary completion	30 June 2022
Estimated completion	30 July 2022
Sites	1 location across Portugal

Drugs / interventions tested

Melatonin and magnesium-containing pod
Placebo comparator

Conditions studied

Sleep Hygiene — all drugs for Sleep Hygiene →
Sleep Disturbance — all drugs for Sleep Disturbance →

Sponsor

Bettery S.A.

Who can join

Adults 35 to 55, any sex, with Sleep Hygiene or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Sleep Hygiene

Currently open trials in the same condition.

NCT07329283 — Nighttime Synchrony of Your Nutrition and Circadian Health · NA · recruiting
NCT04949360 — SleepUp Digital CBTi-based Platform for Insomnia · NA · recruiting
NCT06736951 — Modifying the Inpatient Environment to Reduce Delirium in Older Adults · NA · recruiting
NCT06249217 — Good Nights Sleep Program to Improve Child and Family Sleep · Phase 1, PHASE2 · active not recruiting
NCT06737055 — The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers · NA · recruiting

Other Bettery S.A. trials

Trials by the same sponsor.

NCT05228236 — Plant Based Protein and Whey Protein: Effects on Body Composition and Performance · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05236504 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bettery S.A.
Last refreshed: 1 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05236504.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing