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NCT Number: NCT07029607

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Consumer Research

St. Petersburg, Florida, 33702, United States

Location contact

Lisa Long, PharmD

CONTACT

[email protected]

727-576-7300

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Neurological or psychiatric disorders
  • Pregnant or breastfeeding
  • Known allergies to magnesium-containing products
  • Taking a medication known to interact with magnesium, or taking loop diuretics, cyclosporine, digoxin, amphotericin.
  • No concurrent magnesium supplementation
  • Substance or alcohol abuse
  • 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
  • Anticholinergic or cholinergic medications
  • Anti-inflammatory and analgesic medication (except for PRN use)
  • Anti-allergy medication (except for non-sedating antihistamines)
  • Blood thinners
  • Other prescribed medications that may affect cognition, stress, or mood
  • Body mass index (BMI) greater than 40 kg/m2 ,
  • Individuals on angiotensin converting enzyme inhibitors for blood pressure control, other magnesium-retaining drugs, or potassium-sparing drugs
  • History of reaction to the category of product tested
  • Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
  • Subjects with any invasive medical procedures during the study.
  • Participants who are unreliable or unlikely to be available for the duration of the study.
  • No employees of PCR or the sponsor (e.g OLLY PBC, Unilever, or the H&W Collective)

Treatment and study plan

Placebo

Dietary Supplement

Placebo

Dietary Supplement with actives

Dietary Supplement

Dietary Supplement containing magnesium

Primary outcomes

  1. Changes in PSS scores

    Time frame: 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 outcomes

  1. Changes in Relaxation State Questionnaire scores

    Time frame: 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 outcomes

  1. Changes in PSQI levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Olly, PBC

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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