| Registry | NCT07029607 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 100 (Estimated) |
| Sponsor | Olly, PBC (Industry) |
| Conditions | Healthy |
| Interventions | Placebo, Dietary Supplement with actives (Dietary supplement) |
| Dates | start 2025-07-14 (estimated), primary completion 2025-10-06 (estimated), completion 2025-10-24 (estimated), first posted 2025-06-19, last updated 2025-06-19 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of Placebo All trials of Dietary Supplement with actives
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo | Oral dietary supplement. Instructions: Take 4 gummy per day with or without food or water. Chew thoroughly before swallowing. Do not take more than 4 gummy per day. |
| Dietary Supplement with actives | Active comparator | Dietary Supplement: Dietary Supplement with actives | Oral dietary supplement. Instructions: Take 4 gummy per day with or without food or water. Chew thoroughly before swallowing. Do not take more than 4 gummy per day. |
Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Princeton Consumer Research | St. Petersburg, Florida | United States |