SleepPhase 3NCT05825209
Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity
A Phase 3 study testing Food-Grown Magnesium and Microcrystalline cellulose in people with Sleep, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Food-Grown Magnesium and Microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Apr 2023to 4 Jul 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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)
- 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.
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food-Grown Magnesium Supplement on Sleep Quality/Quantity in a Healthy Adult Population: A Double Blind Randomized Placebo-controlled Study
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
- Being tested
- Food-Grown Magnesium, Microcrystalline cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-Grown MagnesiumDrug
1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule)
Microcrystalline celluloseDrug
1 daily dose of 2 capsules containing microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Food-Grown Magnesium | Active comparator | Food-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep. Receives: Drug: Food-Grown Magnesium |
| Microcrystalline cellulose | Placebo comparator | Microcrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep. Receives: Drug: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 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).
Measured: Baseline, week 1, week 4 and week 8
Secondary outcomes (12)
Change in quality of life
Change in quality of life as assessed by the Short Form 36 Health Survey Questionnaire (SF36) which consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Measured: Baseline and week 8
Change in height in anthropometry measurements
Height as measured by stadiometer in centimeters
Measured: Baseline and week 8
Change in weight in anthropometry measurements
Weight as measured by digital scales in kilograms
Measured: Baseline and week 8
Change in BMI in anthropometry measurements
Height and will be combined to report BMI in kg/m2
Measured: Baseline and week 8
Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline, week 4 and week 8
Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M).
Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M). Participants are asked "How long did it take you to fall asleep?"
Measured: Baseline, week 1, week 4 and week 8
Change in sleep onset time as assessed by wrist actigraphy
Change in sleep onset time as assessed by wrist actigraphy which measures wrist movements to assess sleep or waking state.
Measured: Baseline, week 1, week 4 and week 8
Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI). Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline, week 4 and week 8.
Change in sleep pattern disturbance as assessed by wrist actigraphy
Change in sleep pattern disturbance as assessed by wrist actigraphy which measures wrist movements to assess sleep or waking state.
Measured: Baseline, week 1, week 4 and week 8
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) which is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. The ESS score (the sum of 8 item scores) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity or their 'daytime sleepiness'.
Measured: Baseline, week 4 and week 8
Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire
Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire. Ten component scores are derived, each scored 0 (none) to 4 (very severe). The component scores are summed to produce a global score (range 0 to 40). Higher scores indicate more severe symptoms.
Measured: Baseline, week 4 and week 8
Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21)
Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21) comprising 21 questions all with a rating scale from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). The total score represents overall distress (0 to 30), with higher scores indicating more severe distress or a greater number of symptoms.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start6 Apr 2023
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amanda Rao, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825209
- Sponsor's protocol ID
- MAGSLE
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-Grown Magnesium Supplement on Sleep Quality/Quantity in a Healthy Adult Population: A Double Blind Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05825209
- Acronym / sponsor ID
- MAGSLE
- Conditions
- Sleep
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food-Grown Magnesium | Active comparator | Drug: Food-Grown MagnesiumFood-grown magnesium in capsule form - taken as 2 capsules, orally with water 1 hour before sleep. |
| Microcrystalline cellulose | Placebo comparator | Drug: Microcrystalline celluloseMicrocrystalline cellulose in capsule form - taken as 2 capsules, orally with water 1 hour before sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food-Grown Magnesium1 daily dose of 2 capsules equivalent to 80mg food-grown magnesium (40mg per capsule) | Drug | Food-Grown Magnesium |
| Microcrystalline cellulose1 daily dose of 2 capsules containing microcrystalline cellulose | Drug | Microcrystalline cellulose |
Primary outcome
Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
Time frame: Baseline, week 1, week 4 and week 8
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'
Change in sleep quantity by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M).
Time frame: Baseline, week 1, week 4 and week 8
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).
12 secondary outcomes
Change in quality of life
Time frame: Baseline and week 8
Change in height in anthropometry measurements
Time frame: Baseline and week 8
Change in weight in anthropometry measurements
Time frame: Baseline and week 8
Change in BMI in anthropometry measurements
Time frame: Baseline and week 8
Change in sleep onset time as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, week 4 and week 8
Change in sleep onset time as assessed by self-reported assessment of sleep quality via Consensus Sleep Diary - Morning Administration (CSD-M).
Time frame: Baseline, week 1, week 4 and week 8
Change in sleep onset time as assessed by wrist actigraphy
Time frame: Baseline, week 1, week 4 and week 8
Change in sleep pattern disturbance as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, week 4 and week 8.
Change in sleep pattern disturbance as assessed by wrist actigraphy
Time frame: Baseline, week 1, week 4 and week 8
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Time frame: Baseline, week 4 and week 8
Change in restless legs symptoms as assessed by the Restless Legs Syndrome Questionnaire
Time frame: Baseline, week 4 and week 8
Change in anxiety and stress levels as assessed by the Depression Anxiety and Stress Scale (DASS-21)
Time frame: Baseline and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No. No IPD will be shared
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Rao, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Food-Grown Magnesium and Microcrystalline cellulose in people with Sleep, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality by self-reported assessment via Consensus Sleep Diary - Morning Administration (CSD-M). (time frame: Baseline, week 1, week 4 and week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.