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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05825209




Registration number
NCT05825209
Ethics application status
Date submitted
27/03/2023
Date registered
24/04/2023
Date last updated
24/10/2023

Titles & IDs
Public title
Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity
Scientific title
Food-Grown Magnesium Supplement on Sleep Quality/Quantity in a Healthy Adult Population: A Double Blind Randomized Placebo-controlled Study
Secondary ID [1] 0 0
MAGSLE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Food-Grown Magnesium
Treatment: Drugs - Microcrystalline cellulose

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

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


Treatment: Drugs: Food-Grown Magnesium
1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)

Treatment: Drugs: Microcrystalline cellulose
1 daily dose of 2 capsules containing microcrystalline cellulose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
Timepoint [1] 0 0
Baseline, week 1, week 4 and week 8
Primary outcome [2] 0 0
Change in sleep quantity by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
Timepoint [2] 0 0
Baseline, week 1, week 4 and week 8
Secondary outcome [1] 0 0
Change in quality of life
Timepoint [1] 0 0
Baseline and week 8
Secondary outcome [2] 0 0
Change in height in anthropometry measurements
Timepoint [2] 0 0
Baseline and week 8
Secondary outcome [3] 0 0
Change in weight in anthropometry measurements
Timepoint [3] 0 0
Baseline and week 8
Secondary outcome [4] 0 0
Change in BMI in anthropometry measurements
Timepoint [4] 0 0
Baseline and week 8
Secondary outcome [5] 0 0
Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [5] 0 0
Baseline, week 4 and week 8
Secondary outcome [6] 0 0
Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M).
Timepoint [6] 0 0
Baseline, week 1, week 4 and week 8
Secondary outcome [7] 0 0
Change in sleep onset time as assessed by wrist actigraphy
Timepoint [7] 0 0
Baseline, week 1, week 4 and week 8
Secondary outcome [8] 0 0
Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [8] 0 0
Baseline, week 4 and week 8.
Secondary outcome [9] 0 0
Change in sleep pattern disturbance as assessed by wrist actigraphy
Timepoint [9] 0 0
Baseline, week 1, week 4 and week 8
Secondary outcome [10] 0 0
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Timepoint [10] 0 0
Baseline, week 4 and week 8
Secondary outcome [11] 0 0
Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire
Timepoint [11] 0 0
Baseline, week 4 and week 8
Secondary outcome [12] 0 0
Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21)
Timepoint [12] 0 0
Baseline and week 8

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other clinical trial during the past 6 months
* Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
* History of infection in the month prior to the study
* Regularly taking stimulants (e.g., coffee, caffeine supplements, caffeine containing beverages) 2 hours before bed
* Disturbed sleeping pattern caused by external factors (e.g., children, partner, noises)

1. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
2. Insomnia has been excluded as it is a significant health condition, and we are testing on otherwise healthy participants (as per TGA complementary medicine requirements)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2023
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Global Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05825209
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Rao, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05825209