A Randomized Double Blind, Placebo Controlled Clinical Study Evaluating the Efficacy and Safety of Magnesium Supplementation on Relaxation in Adults

Not Applicable

Not yet recruiting

• Conditions: Healthy

• Registration Number: NCT07029607
• Lead Sponsor: Olly, PBC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Study Start: 2025-07-14
• Primary Completion: 2025-10-06
• Study Completion: 2025-10-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Princeton Consumer Research; 🇺🇸 Saint Petersburg, Florida, United States