HealthyNCT07029607
A Randomized Double Blind, Placebo Controlled Clinical Study Evaluating the Efficacy and Safety of Magnesium Supplementation on Relaxation in Adults
A study testing Dietary Supplement with actives in people with Healthy, run by Olly, PBC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dietary Supplement with actives
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 24 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Princeton Consumer Research
St. Petersburg, Florida, 33702
Lisa Long, PharmD, 727-576-7300, lisalong@princetonconsumer.com
About this study
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.
- Conditions
- Healthy
- Being tested
- Placebo, Dietary Supplement with actives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
Dietary Supplement with activesDietary supplement
Dietary Supplement containing magnesium
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Dietary Supplement with actives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PSS scores
Monthly PSS scores will be analyzed to assess changes in stress levels across the actives and the placebo
Measured: From start of study until end of the study at week 12
Secondary outcomes (1)
Changes in Relaxation State Questionnaire scores
Monthly RSQ scores will be analyzed to assess the changes in mind and body relaxation levels across the actives and placebo
Measured: From start of study until end of the study at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start14 Jul 2025 (estimated)
- Primary completion6 Oct 2025 (estimated)
- Study completion24 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olly, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029607
- Sponsor's protocol ID
- OLLCLI2F
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind, Placebo Controlled Clinical Study Evaluating the Efficacy and Safety of Magnesium Supplementation on Relaxation in Adults
- ClinicalTrials.gov ID
- NCT07029607
- Acronym / sponsor ID
- OLLCLI2F
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Olly, PBCIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2025 (estimated)
- Primary completion
- 6 Oct 2025 (estimated)
- Study completion
- 24 Oct 2025 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOral 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 with actives | Active comparator | Dietary Supplement: Dietary Supplement with activesOral 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | Placebo |
| Dietary Supplement with activesDietary Supplement containing magnesium | Dietary supplement | Dietary Supplement with actives |
Primary outcome
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
1 secondary outcome
Changes in Relaxation State Questionnaire scores
Time frame: From start of study until end of the study at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement with actives in people with Healthy, run by Olly, PBC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PSS scores (time frame: From start of study until end of the study at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.