A Randomized Double Blind, Placebo Controlled Clinical Study Evaluating the Efficacy and Safety of Magnesium Supplementation on Relaxation in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Dietary Supplement with actives.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement Placebo
Placebo - Dietary supplement Dietary Supplement with actives
Dietary Supplement containing magnesium
Primary outcome measures
- Changes in PSS scores [Time frame: From start of study until end of the study at week 12]
Secondary outcome measures (1)
- Changes in Relaxation State Questionnaire scores [Time frame: From start of study until end of the study at week 12]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Princeton Consumer Research — St. Petersburg
Identifiers
NCT: NCT07029607 · OLLCLI2F