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

Olly, PBC

Status: Not yet enrolling

Conditions: Healthy

Treatments: Dietary Supplement: Dietary Supplement with actives; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07029607

OLLCLI2F

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement with actives

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Dietary Supplement with actives