HealthyNCT07076537
A Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
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 be a randomized, placebo control clinical study to assess the the efficacy for improvement of mood/stress and anxiety compared to placebo through validated survey questionnaire. The target population of this study is 5 to 14 years old. Read more about this study
- Who is it for?
- Ages 5 to 14 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
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 2 Sep 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Willingness to actively participate in the study and to come to the scheduled visits.
- Healthy (Healthy as determined by medical history as assessed by Qualified Investigator ) female and male subjects in good health between 5 to 14 years old.
- Enrolled in and currently attending school at baseline and for the duration of the study period.
- 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.
- Ability to give consent (assent) for participation in the study
Who cannot join
- Diagnosed with any mental health condition including chronic stress, GAD, impaired cerebral function, mood disorders, ADHD or similar conditions
- Currently taking any prescription medications or dietary supplements for sleep, anxiety, depression or ADHD
- Liver dysfunction
- Use of sleep aides including dietary supplements over the past 7 days
- 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.
Show all 12Show fewer
- Participants having an acute or chronic disease or medical condition could put him/her at risk in the opinion of the Principal Investigator or compromise study outcomes.
- Typical uncontrolled chronic or serious disease and/or conditions which would prevent participation in any clinical trials such as cancer, AIDs, diabetes, renal- impairment, mental illness, drug/alcohol addiction.
- Subjects with a history of cancer within the past 5 years.
- Subjects with any planned surgeries and/or invasive medical procedures during the study.
- Individuals unable to communicate or cooperate with the principal investigator due to language
- Employees (and children of employees) of TKL and/or product brand owner or manufacturer.
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
TKL Research
Fair Lawn, New Jersey, 07410
John Lyssikatos
About this study
Official title: A Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
The study will be a randomized, placebo control clinical study to assess the the efficacy for improvement of mood/stress and anxiety compared to placebo through validated survey questionnaire. The target population of this study is 5 to 14 years old. Participants will be asked to take questionnaires to collect baseline at the beginning of the study. The questionnaires are: Perceived Stress Scale for children (PSS-ch), The Positive Affect and Negative Affect Schedule-Child Form-children (PANAS-children) and the Children's Sleep Habits Questionnaire (CSHQ). The interventional treatment will be for a total of 4 weeks (28 days). Participants will be asked to take the questionnaires at the end of the 28 days. The subjects will attend two appointments in the clinic throughout the duration of the study.
Read the detailed description
For these scale, here are some more details:
The PSS-C:
Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56.
Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.
The PANAS-C:
Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in:
- Positive Affect (PA): 15 to 75
- Negative Affect (NA): 15 to 75
Interpretation:
Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)
The CSHQ Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99.
Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.
- 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, L-theanine and lemon balm extract
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral dietary supplement. Instructions: Take 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m. Receives: Dietary Supplement: Placebo |
| Dietary Supplement with actives | Active comparator | Oral dietary supplement. Instructions: Take 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m. Receives: Dietary Supplement: Dietary Supplement with actives |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.
PSS-children will be administered before the intervention to establish baseline, 40 min after taking the initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement in stress levels across the active and placebo arms. Data will be compared between the active supplement and placebo groups.
More details on the scales
The PSS-C: (perceived stress scale -children form) Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56.
Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.
Measured: from enrollment to end of study at Week 4
Secondary outcomes (2)
To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire.
PANAS-children questionnaire will be administered before the intervention, to establish baseline, 40 min after initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement of positive and negative mood across the active and placebo arms. Data will be compared between the active supplement and placebo groups.
More details on scale:
The PANAS-C: (positive and negative affect scale-children form)
Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in:
- Positive Affect (PA): 15 to 75
- Negative Affect (NA): 15 to 75
Interpretation:
Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)
Measured: from enrollment to end of study at Week 4
To assess the efficacy for improvement of sleep quality compared to placebo through validated survey questionnaire.
CSHQ questionnaire will be administered before the intervention, to establish baseline, and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement sleep quality across the active and placebo arms. Data will be compared between the active supplement and placebo groups.
More details on scale:
The CSHQ (children sleep habits questionnaire) Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99.
Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.
Measured: from enrollment to end of study at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion2 Sep 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
- 80 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
- NCT07076537
- Sponsor's protocol ID
- ULOLLYKC2
- Status last verified
- Jul 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population
- ClinicalTrials.gov ID
- NCT07076537
- Acronym / sponsor ID
- ULOLLYKC2
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Olly, PBCIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 22 Jul 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 be a randomized, placebo control clinical study to assess the the efficacy for improvement of mood/stress and anxiety compared to placebo through validated survey questionnaire. The target population of this study is 5 to 14 years old. Participants will be asked to take questionnaires to collect baseline at the beginning of the study. The questionnaires are: Perceived Stress Scale for children (PSS-ch), The Positive Affect and Negative Affect Schedule-Child Form-children (PANAS-children) and the Children's Sleep Habits Questionnaire (CSHQ). The interventional treatment will be for a total of 4 weeks (28 days). Participants will be asked to take the questionnaires at the end of the 28 days. The subjects will attend two appointments in the clinic throughout the duration of the study.
Detailed description
For these scale, here are some more details:
The PSS-C:
Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56.
Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.
The PANAS-C:
Scoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in:
- Positive Affect (PA): 15 to 75
- Negative Affect (NA): 15 to 75
Interpretation:
Higher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)
The CSHQ Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99.
Interpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.
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 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m. |
| Dietary Supplement with actives | Active comparator | Dietary Supplement: Dietary Supplement with activesOral dietary supplement. Instructions: Take 2 gummies per day as needed. Chew thoroughly before swallowing. Ideally, take in the morning at the same time between 8:00 a.m. and 11:00 a.m. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Willingness to actively participate in the study and to come to the scheduled visits.
- Healthy (Healthy as determined by medical history as assessed by Qualified Investigator ) female and male subjects in good health between 5 to 14 years old.
- Enrolled in and currently attending school at baseline and for the duration of the study period.
- 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.
- Ability to give consent (assent) for participation in the study
Key exclusion criteria (12 listed)
- Diagnosed with any mental health condition including chronic stress, GAD, impaired cerebral function, mood disorders, ADHD or similar conditions
- Currently taking any prescription medications or dietary supplements for sleep, anxiety, depression or ADHD
- Liver dysfunction
- Use of sleep aides including dietary supplements over the past 7 days
- History of reaction to the category of product tested
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, L-theanine and lemon balm extract | Dietary supplement | Dietary Supplement with actives |
Primary outcome
To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.
Time frame: from enrollment to end of study at Week 4
PSS-children will be administered before the intervention to establish baseline, 40 min after taking the initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement in stress levels across the active and placebo arms. Data will be compared between the active supplement and placebo groups. More details on the scales The PSS-C: (perceived stress scale -children form) Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56. Interpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.
2 secondary outcomes
To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire.
Time frame: from enrollment to end of study at Week 4
To assess the efficacy for improvement of sleep quality compared to placebo through validated survey questionnaire.
Time frame: from enrollment to end of study at Week 4
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 22 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 5 inclusion and 12 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 22 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire. (time frame: from enrollment to end of study at Week 4). 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 22 Jul 2025.