Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity

NCT05825209 | Completed Phase 3

• 1 other identifier: MAGSLE
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double-blind randomised placebo-controlled trial to evaluate orally-dosed food-grown magnesium compared to placebo on improvement in sleep quality and quantity as well as quality of life in otherwise healthy participants aged 18 years and older.

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).

  Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M). Sleep quality is assessed by a 5 category rating from 'Very poor' to 'Very good'. Sleep quality is also assessed by a 5 category rating of the degree of rested state from 'Not at all rested' to "Very well-rested'

  Baseline, week 1, week 4 and week 8

• Change in sleep quantity by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).

  Change in sleep quantity, as defined as the collective amount of sleep obtained in a given period, by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).

  Baseline, week 1, week 4 and week 8

Secondary Outcomes (12)

• Change in quality of life

  Baseline and week 8

• Change in height in anthropometry measurements

  Baseline and week 8

• Change in weight in anthropometry measurements

  Baseline and week 8

• Change in BMI in anthropometry measurements

  Baseline and week 8

• Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, week 4 and week 8

Other Outcomes (3)

• Adverse Events self-reported by participants

  8 week period from enrolment to participant conclusion

• Change in medication use

  Baseline, week 1, week 4 and week 8

• Investigational product dosing compliance

  Baseline, week 1, week 4 and week 8

Study Arms (2)

Food-Grown Magnesium

ACTIVE COMPARATOR

Food-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.

Drug: Food-Grown Magnesium

Microcrystalline cellulose

PLACEBO COMPARATOR

Microcrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep.

Drug: Microcrystalline cellulose

Interventions

Food-Grown Magnesium DRUG

1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)

Food-Grown Magnesium

Microcrystalline cellulose DRUG

1 daily dose of 2 capsules containing microcrystalline cellulose

Microcrystalline cellulose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years or older
• Otherwise healthy
• Disturbed sleeping pattern (defined as difficulty falling asleep, waking up during the sleep cycle or waking up too early and being unable to fall back to sleep)
• Able to provide informed consent
• Agree not to change current diet/exercise or not to use other medicines or supplements for sleep or anxiety other than the test product during entire study period.
• Agree not to participate in another clinical trial while enrolled in this trial

You may not qualify if:

• Unstable or serious illness (e.g. serious mood disorders such as depression or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease, GIT conditions, heart conditions, diabetes, thyroid gland function) (1)
• History of renal function impairment
• Regular sleeping pattern
• Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
• Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
• Receiving/prescribed sleep or anxiety medication/aid
• Sleep apnea
• Diagnosed or consistent gastrointestinal issues that disrupt sleep
• Active smokers, nicotine use, drug abuse
• Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
• Allergic to any of the ingredients in active or placebo formula
• People with serious mood disorders (such as depression, anxiety and bipolar disorder) will be excluded
• Those suffering from insomnia or have night-shift employment and unable to have a normal night's sleep (2)
• People suffering any neurological disorders such as MS
• Pregnant or lactating woman

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Global Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Interventions

microcrystalline cellulose

Study Officials

• Amanda Rao, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 24, 2023
• Study Start: April 6, 2023
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)