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

NCT ID: NCT07029607

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-14

Study Completion Date

2025-10-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Group Type ACTIVE_COMPARATOR

Dietary Supplement with actives

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement containing magnesium

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement with actives

Dietary Supplement containing magnesium

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Olly, PBC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Princeton Consumer Research

St. Petersburg, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lisa Long, PharmD

Role: primary

727-576-7300

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OLLCLI2F

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Magnesium and Vascular Stiffness
NCT03632590 UNKNOWN NA
Cognitive Vitality Pilot Study
NCT07208279 RECRUITING NA