Healthy
Conditions
Brief summary
The study will assess the efficacy of magnesium supplementation for improvement of body and mind relaxation (through stress levels), and sleep score compared to placebo, assessed by validated questionnaires. Participants will be asked to take the supplement every day for 12 weeks and will complete monthly check-ins and questionnaires. Participants will monitor adverse events in a journal.
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo
DIETARY_SUPPLEMENTDietary Supplement with actives
Dietary Supplement containing magnesium
Sponsors
Olly, PBC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants (women + men) * Will maintain regular diet and exercise habits * Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
Exclusion criteria
1. Neurological or psychiatric disorders 2. Pregnant or breastfeeding 3. Known allergies to magnesium-containing products 4. Taking a medication known to interact with magnesium, or taking loop diuretics, cyclosporine, digoxin, amphotericin. 5. No concurrent magnesium supplementation 6. Substance or alcohol abuse 7. Currently use, or have used within appropriate washout period, any prescription, over the counter medication, or supplements with primary CNS activity such as Antidepressants,mood stabilizer and anxiolytics, Sedatives and Stimulants 8. Anticholinergic or cholinergic medications 9. Anti-inflammatory and analgesic medication (except for PRN use) 10. Anti-allergy medication (except for non-sedating antihistamines) 11. Blood thinners 12. Other prescribed medications that may affect cognition, stress, or mood 13. Body mass index (BMI) greater than 40 kg/m2 , 14. Individuals on angiotensin converting enzyme inhibitors for blood pressure control, other magnesium-retaining drugs, or potassium-sparing drugs 15. History of reaction to the category of product tested 16. Other diseases or medications that might directly interfere in the study or put the subject's health under risk. 17. Subjects with any invasive medical procedures during the study. 18. Participants who are unreliable or unlikely to be available for the duration of the study. 19. No employees of PCR or the sponsor (e.g OLLY PBC, Unilever, or the H&W Collective)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PSS scores | From start of study until end of the study at week 12 | Monthly PSS scores will be analyzed to assess changes in stress levels across the actives and the placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Relaxation State Questionnaire scores | From start of study until end of the study at week 12 | Monthly RSQ scores will be analyzed to assess the changes in mind and body relaxation levels across the actives and placebo |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in PSQI levels | From start of study until end of the study at week 12 | Monthly PSQI scores will be analyzed to assess the changes sleep quality across the actives and placebo |
Countries
United States
Outcome results
None listed