Does magnesium improve adults' sleep, mood, and anxiety?
| ISRCTN | ISRCTN14728094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14728094 |
- Submission date
- 11/04/2024
- Registration date
- 15/04/2024
- Last edited
- 12/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Globally, many adults struggle with poor sleep quality. This is worrying because it's linked to various health issues like obesity, diabetes, and mental health problems like depression. Poor sleep can also make us feel cranky, anxious, and less productive.
Magnesium, a mineral found in our bodies, might help improve sleep. It plays a role in brain function and helps regulate chemicals that affect relaxation and sleepiness. It's also involved in making melatonin, a hormone that helps us sleep.
Some studies suggest that people who don't get enough sleep tend to have lower levels of magnesium in their bodies. Other research has found that magnesium supplements can help improve sleep quality and maintain a normal sleep-wake cycle.
There's a special type of magnesium called magnesium-L-threonate (MgT) that might be even better at getting into the brain where it's needed. Animal studies have shown that MgT can improve memory, reduce anxiety, and enhance brain function. Similar benefits have been seen in humans too.
To see if MgT could also help with sleep troubles a study was conducted where some people took MgT supplements for 21 days, while others took a placebo (a fake pill).
Who can participate?
People aged 35 to 55 years who reported poor sleep quality
What does the study involve?
Participants complete psychometric self-report questionnaires on day 0 (baseline), day 7, day 14, and day 21 and maintain a daily diary to document subjective sleep aspects, adherence, and adverse events. Participants also wear an Oura Ring to objectively determine sleep and daytime activity. Participants maintain their current lifestyle behaviors and do not engage in any new forms of structured exercise or begin a new diet or health intervention during the study. Participants do not visit a clinic, and all recruitment, contact, screening, consenting, and assessments are performed online.
What are the possible benefits and risks of participating?
Participants may develop a better understanding of their health and sleep. They will not lose any services, benefits, or rights they would normally have if they chose not to volunteer.
Where is the study run from?
AIDP, Inc. (USA)
When is the study starting and how long is it expected to run for?
January 2022 to April 2023
Who is funding the study?
AIDP, Inc. (USA)
Who is the main contact?
Heather Hausenblas, PhD, hhausenblas@wellnessdiscoverylabs.com
Contact information
Public, Scientific, Principal Investigator
3525 Pine St
Jacksonville
32205
United States of America
 ORCID ID |
0000-0002-0127-9184 |
|---|---|
| Phone | +1 (0)9048919746 |
| hhausenblas@wellnessdiscoverylabs.com |
Study information
| Study design | Randomized double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Scientific title | Effectiveness of magnesium supplementation (i.e., Magtein®) on anxiety, mood, and sleep quality of adults with poor sleep quality and nonclinical anxiety: a randomized, double-blind, placebo-controlled trial |
| Study hypothesis | Daily magnesium supplementation would result in significantly improved quality of sleep, mood, daily activity, energy, mental alertness, and daytime productivity, as compared to the placebo |
| Ethics approval(s) |
Approved 10/03/2022, Sterling IRB (6300 Powers Ferry Rd, Suite 600-351, Atlanta, 30339, United States of America; +1 (0)770 690 9491; support@sterlingirb.com), ref: Protocol Number 9806 |
| Condition | Nonclinical poor sleep and anxiety |
| Intervention | A randomized double-blind placebo-controlled, parallel-arm trial design per CONSORT was employed, with participants randomly assigned using a random number function in Excel to either the MgT or placebo (comprising rice protein) for a duration of 3 weeks. Participants were directed to consume 1 g/d of the testing products: two capsules each containing 500 mg MgT or placebo (rice protein) 2 hours before bedtime. The MgT supplement used, Magtein®, is a brain-bioavailable magnesium L-threonate, a product of Threotech LLC (NV, USA), containing about 75 mg/g of elemental magnesium. Eligible participants provided institutional review board-approved informed consent prior to enrollment. Participants were to complete psychometric self-report questionnaires on day 0 (baseline), day 7, day 14, and day 21. In addition, participants were to maintain a daily diary to document subjective sleep aspects, adherence, and adverse events. Participants also wore an Oura Ring to objectively determine sleep and daytime activity. Participants maintained their current lifestyle behaviors and did not engage in any new forms of structured exercise or begin a new diet or health intervention during the trial. As a decentralized trial, participants did not visit a clinic, and all recruitments, contact, screening, consenting, and assessments were performed online. |
| Intervention type | Supplement |
| Primary outcome measure | 1. Sleep quality measured with the Insomnia Severity Index at Baseline, Week 1, Week 2, and Week 3 2. Sleep quality measured with the Leeds Sleep Evaluation Questionnaire at Baseline, Week 1, Week 2, and Week 3 3. Sleep quality measured with the Restorative Sleep Questionnaire at Baseline, Week 1, Week 2, and Week 3 4. Sleep quality assessed with the Oura Ring nightly for 3 weeks |
| Secondary outcome measures | 1. Daily activity assessed with the Oura Ring daily for 3 weeks 2. Mood states assessed with the Trait Anxiety Inventory and the Profile of Mood States at Baseline, Week 1, Week 2, and Week 3 3. Adherence, safety, sleep quality/daytime activity, and events affecting sleep assessed with the Daily Diary daily for 3 weeks 4. Study perceived effectiveness assessed using post-study self-report assessments at Week 3 |
| Overall study start date | 01/01/2022 |
| Overall study end date | 09/04/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Participant inclusion criteria | 1. Individuals who reported poor sleep quality, determined by a score of 8-21 on the Insomnia Severity Index (Bastien et al., 2001) 2. Weight between 50-100 kg (i.e., 110-220 lbs) 3. Not meeting any of the exclusion criteria |
| Participant exclusion criteria | 1. A history of sleep-affecting disorders 2. Recent highly stressful events within 2 weeks of baseline 3. Use of sleep supplements or medications 4. Usage of sleep-pattern-influencing medications within 1 month of baseline 5. Use of calcium channel blockers, anxiolytics or SSRIs, no more than 5 times per month, and not within 7 days of baseline 6. Current hormone therapy 7. Unstable use of other medication 8. Excessive alcohol consumption 9. Smoking 10. Elevated caffeine intake 11. Irregular sleep-inducing work schedules 12. Recent travel to different time zones within 1 month of study 13. Pregnancy, attempts at conception, or breastfeeding 14. Refusal to abstain from other magnesium products for 2 weeks before and during the trial 15. Individuals incompatible with the study protocol |
| Recruitment start date | 01/05/2022 |
| Recruitment end date | 01/11/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Jacksonville
32202
United States of America
Sponsor information
Industry
19535 E Walnut Drive South
City of Industry
91748
United States of America
| Phone | +1 (0)626 964 6910 |
|---|---|
| CustomerCare@aidp.com | |
| Website | https://aidp.com |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset generated during the current study will be available upon request from Doug Rosendale (d.rosendale@aidp.com). The type of data that will be shared: anonymous data in an Excel format. In the informed consent document participants were informed of the following: “De-identified limited data set and aggregate study findings may be shared with the study sponsor. The limited data set will only include information that does not directly identify you. For example, the limited data set will not include name, address, telephone number, or other codes that link you to the information in the limited data set. Aggregate findings (no identifiers in the data) may be shared via scientific publication or professional presentations.” Participants were informed of the following on the IRB-approved consent form: “You will be assigned a study-specific code number. The study investigators will store the key linking your name with the study code on a password-protected computer. A code number will be assigned at the beginning of the study. Only your code number will be on the questionnaires to identify you. There will be no identifying information on any of the survey documents. Electronic data will be stored on a password-protected fileserver. All paper documents with identifying links will be destroyed at the end of the study.” |
Editorial Notes
11/04/2024: Study's existence confirmed by Sterling IRB.
