NCT07029607

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

July 14, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 11, 2025

Last Update Submit

June 18, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Changes in PSS scores

    Monthly PSS scores will be analyzed to assess changes in stress levels across the actives and the placebo

    From start of study until end of the study at week 12

Secondary Outcomes (1)

  • Changes in Relaxation State Questionnaire scores

    From start of study until end of the study at week 12

Other Outcomes (1)

  • Changes in PSQI levels

    From start of study until end of the study at week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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: Placebo

Dietary Supplement with actives

ACTIVE COMPARATOR

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: Dietary Supplement with actives

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo
Dietary Supplement with activesDIETARY_SUPPLEMENT

Dietary Supplement containing magnesium

Dietary Supplement with actives

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princeton Consumer Research

St. Petersburg, Florida, 33702, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

July 14, 2025

Primary Completion

October 6, 2025

Study Completion

October 24, 2025

Last Updated

June 19, 2025

Record last verified: 2025-06

Locations

US(1)