Memory DeficitsNCT05520424
An Exploratory Investigation of a Supplement to Promote Brain Health
A study testing The Daily Supplement in people with Memory Deficits and Cognitive Change, run by Parable at 1 site in United States.
Trial summary
Providing a combination of synergistic dietary supplements, such as vitamins B6, B12, and folate, as well as curcumin, lemon balm, and American ginseng is hypothesized to promote brain health and aid with brain fog, mental clarity, ability to handle stress, mood, focus, and productivity, as well as promote overall… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Deficits, Cognitive Change, Stress
- What is being tested?
- The Daily Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.)
Who cannot join
- Females who are pregnant or breastfeeding
- Anyone currently taking other supplements
- Anyone with a known allergic reaction
- Previous head trauma
- Anyone with chronic diseases such as diabetes, coronary heart disease, or cancer.
- Any psychological, mental, or neurodevelopmental disorders
Show all 9Show fewer
- Consumes nicotine or marijuana in any form
- Previous or current alcohol addiction
- Consume more than 10 drinks per week
Trial locations and contacts
1 site in 1 country.
About this study
Providing a combination of synergistic dietary supplements, such as vitamins B6, B12, and folate, as well as curcumin, lemon balm, and American ginseng is hypothesized to promote brain health and aid with brain fog, mental clarity, ability to handle stress, mood, focus, and productivity, as well as promote overall well-being.
- Conditions
- Memory Deficits, Cognitive Change, Stress
- Being tested
- The Daily Supplement
- Keywords
- Focus, Memory, Attention, Stress
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Daily SupplementDietary supplement
The ingredient list of the product includes the following:
400mg of curcumin (Longvida) 300mg of lemon balm extract (Cyracos) 200mg of American ginseng (Cereboost) 50mg of epigallocatechin gallate derived from green tea Organic oat milk powder Phosphatidylserine (SerinAid) (active) B6 (in the form of P5P) Folate (Quatrefolic) B12 Silica (non-active)
| Study group | Role | What they receive |
|---|---|---|
| The Daily Supplement | Experimental | Participants will use test product daily, and complete Biomarker assessments (at 1st dose, Day 7, Day 31), as well as surveys (at 1st dose, Day 7, Day 31), and Cognitive battery Assessments (at 1st dose, Day 7, Day 31). Receives: Dietary Supplement: The Daily Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived changes in mental health symptoms as measured by Questionnaires
Questionnaires measure perceived changes in mental health symptoms (e.g., anxiety levels, mental clarity) and stress management on a scale of 0 (low levels of mental health symptoms) to 10 (very high levels of mental health symptoms)
Measured: 31 days
Perceived changes in stress management as measured by Questionnaires
Questionnaires measure perceived changes in stress management on a scale of 0 (poor ability to manage stress) to 10 (excellent ability to manage stress)
Measured: 31 days
Secondary outcomes (1)
Changes in Cognitive Functioning
Cognitive battery questionnaires measure executive functioning, long term memory, working memory, and attention.
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start15 Jun 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory DeficitsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parable
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Christopher Hill, PhD, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520424
- Sponsor's protocol ID
- 20251
- Status last verified
- Apr 2024
- First submitted
- 26 Aug 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of a Supplement to Promote Brain Health
- ClinicalTrials.gov ID
- NCT05520424
- Acronym / sponsor ID
- 20251
- Conditions
- Memory Deficits, Cognitive Change, Stress
- Keywords
- Focus, Memory, Attention, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ParableIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 29 Aug 2022 (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.
Providing a combination of synergistic dietary supplements, such as vitamins B6, B12, and folate, as well as curcumin, lemon balm, and American ginseng is hypothesized to promote brain health and aid with brain fog, mental clarity, ability to handle stress, mood, focus, and productivity, as well as promote overall well-being.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Daily Supplement | Experimental | Dietary Supplement: The Daily SupplementParticipants will use test product daily, and complete Biomarker assessments (at 1st dose, Day 7, Day 31), as well as surveys (at 1st dose, Day 7, Day 31), and Cognitive battery Assessments (at 1st dose, Day 7, Day 31). |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.)
Key exclusion criteria (9 listed)
- Females who are pregnant or breastfeeding
- Anyone currently taking other supplements
- Anyone with a known allergic reaction
- Previous head trauma
- Anyone with chronic diseases such as diabetes, coronary heart disease, or cancer.
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 |
|---|---|---|
| The Daily SupplementThe ingredient list of the product includes the following: 400mg of curcumin (Longvida) 300mg of lemon balm extract (Cyracos) 200mg of American ginseng (Cereboost) 50mg of epigallocatechin gallate derived from green tea Organic oat milk powder Phosphatidylserine (SerinAid) (active) B6 (in the form of P5P) Folate (Quatrefolic) B12 Silica (non-active) | Dietary supplement | The Daily Supplement |
Primary outcome
Perceived changes in mental health symptoms as measured by Questionnaires
Time frame: 31 days
Questionnaires measure perceived changes in mental health symptoms (e.g., anxiety levels, mental clarity) and stress management on a scale of 0 (low levels of mental health symptoms) to 10 (very high levels of mental health symptoms)
Perceived changes in stress management as measured by Questionnaires
Time frame: 31 days
Questionnaires measure perceived changes in stress management on a scale of 0 (poor ability to manage stress) to 10 (excellent ability to manage stress)
1 secondary outcome
Changes in Cognitive Functioning
Time frame: 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Christopher Hill, PhD principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Daily Supplement in people with Memory Deficits and Cognitive Change, run by Parable 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 3 Apr 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived changes in mental health symptoms as measured by Questionnaires (time frame: 31 days). The study lists 2 primary outcomes in all. 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 3 Apr 2024.