How taking magnesium affects sleep and health in adults with poor sleep quality: a study with randomized blinding and placebo control
| ISRCTN | ISRCTN70584524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70584524 |
| Secondary identifying numbers | UFMag |
- Submission date
- 08/11/2023
- Registration date
- 09/11/2023
- Last edited
- 09/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
We are conducting a study on healthy adults with occasional sleeplessness to examine the effectiveness of Upgraded Formulas Magnesium supplementation on sleep quality and related health outcomes.
We will assess the participant’s health-related quality of life, fatigue, anxiety, perceived stress, sleep quality, productivity, and mood.
Who can participate?
Adults between the ages of 18 to 65 years who report poor sleep quality
What does the study involve?
Following the baseline assessment, you will be randomized to either the Magnesium Supplementation or Placebo Control condition for 2 weeks. Following a one-week washout period, you will then take the alternative supplement/placebo for2 weeks.
You will be asked to complete assessments at the following time points: Baseline and following taking the supplement and placebo. The assessments will be self-report questionnaires that will take about 20 minutes to complete at each assessment. Each day you will also complete a self-reported daily diary that will ask questions regarding your sleep quality, productivity, mood, and adherence. Completion of the daily diary will take about two minutes. You will also wear an Oura Ring to record your nighttime sleep and daytime activity. Your data will not be linked to other data.
What are the possible benefits and risks of participating?
You may or may not personally benefit from participating in this study. By participating in this study, you may develop a better understanding of your health and sleep levels. If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, benefits, or rights you would normally have if you chose not to volunteer. If you are interested in learning more about the study, please continue to read below. If you are not interested stop here.
Where is the study run from?
Upgraded Formulas (USA)
When is the study starting and how long is it expected to run for?
January 2023 to July 2023
Who is funding the study?
Upgraded Formulas (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 9048919746 |
| hhausenblas@wellnessdiscoverylabs.com |
Study information
| Study design | Randomized double-blind placebo-controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effectiveness of magnesium supplementation on sleep quality and related health outcomes for adults with poor sleep quality: a randomized double-blind placebo-controlled crossover trial |
| Study hypothesis | Nano magnesium chloride supplementation improves sleep quality and health. |
| Ethics approval(s) |
Approved 01/01/2023, Sterling IRB (6300 Powers Ferry Rd Suite 600-351, ATlanta, 30339, United States of America; +1 770-690-9491; info@sterlingirb.com), ref: 10721-HAHausenblas |
| Condition | Adults with nonclinical insomnia symptoms |
| Intervention | For the 2 conditions (magnesium and placebo control) the procedures were identical except for the supplement taken (i.e., either magnesium or control). 1. Magnesium: Participants took the Upgraded Formulas supplement which is a nano magnesium chloride that is 100% natural, keto, organic, and vegan. It is free from artificial flavors, fillers, colors, and stabilizers. Participants were instructed to take 4 capsules 120 minutes or less before bed with 12 oz of water. 2. Control: Participants were instructed to take 4 capsules 120 minutes or less before bed with 12 oz of water. The placebo capsules were sucrose. Total duration of intervention: 5 weeks Follow-up: No follow-up Randomization: 1. Created a List: List of all participants, assigned each a unique identifier or number. 2. Random Selection: Used a random method of computer-generated random number generator to select participants without any bias. 3. Group Assignment: Assigned participants to different groups based on generated assignment. Participants completed psychometrically validated self-report questionnaires at Day 0 (Pre) and post each condition. Participants also completed a Daily Diary to assess subjective sleep quality/quantity, adherence, and adverse events, and 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. |
| Intervention type | Supplement |
| Primary outcome measure | Sleep measured by: 1. Questionnaires: 1.1. Insomnia Severity Index was measured at baseline and post each condition 1.2. Pittsburgh Sleep Quality Index (PSQI) was measured at baseline and post each condition 1.3. Berlin Questionnaire was measured at baseline and post each condition 1.4. Restorative Sleep Questionnaire was measured at baseline and post each condition 2. Objective wearable measure: Oura Ring which is a multisensory wearable device that quantifies night-time and daytime activity was measured daily |
| Secondary outcome measures | 1. Profile of Mood States was measured at baseline and post each condition 2. Flinders Fatigue Scale was measured at baseline and post each condition 3. Perceived Stress Scale was measured at baseline and post each condition 4. Pain and Sleep Questionnaire Three-item Index was measured at baseline and post each condition 5. Trait Anxiety Inventory. was measured at baseline and post each condition 6. Adherence and adverse events: was measured daily via a questionnaire |
| Overall study start date | 01/01/2023 |
| Overall study end date | 07/07/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 31 |
| Total final enrolment | 31 |
| Participant inclusion criteria | Adults between the ages of 25 to 55 with nonclinical insomnia symptoms |
| Participant exclusion criteria | 1. Severe insomnia (based on the Insomnia Severity Index (ISI ≥ 22) or absence of insomnia (ISI < 8); 2. History of a disorder affecting sleep quality 3. Events that could cause severe stress within 2 weeks of baseline 4. Use of medication that could influence sleep patterns, within 1 month of baseline 5. Current use of hormone therapy 6. Binge drinking 7. Smoking 8. High caffeine intake 9. Work schedule that causes irregular sleep patterns 10. History of travel to a different time zone within 1 month of study 11. Low or high body mass index (BMI ≤ 18 kg/m² or ≥30 kg/m²) 12. Pregnant, trying to conceive, or breastfeeding 13. Taking sleep supplements or medication 14. Unwilling to abstain from other magnesium product use for two weeks leading up to trial initiation and during the trial 15. Individuals deemed incompatible with the study protocol |
| Recruitment start date | 03/03/2023 |
| Recruitment end date | 04/04/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Jacksonville
32202
United States of America
Sponsor information
Industry
Barton Scott
300 S Lamar Blvd
Austin
78704
United States of America
| Phone | +1 281.900.1027 |
|---|---|
| barton@upgradedformulas.com | |
| Website | https://www.upgradedformulas.com/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 02/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Submit results for review at a scientific journal |
| IPD sharing plan | Dataset will be available upon request from Heather Hausenblas (hhausenblas@wellnessdiscoverylabs.com) |
Editorial Notes
09/11/2023: Trial's existence confirmed by Sterling IRB.
