Daily Supplement for Cognitive Impairment

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Parable

Must not be taking: Supplements

Disqualifiers: Pregnancy, Allergies, Head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 31 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a daily supplement combining vitamins and herbal ingredients to determine its effects on brain fog, mental clarity, stress management, mood, focus, and productivity. Researchers aim to discover if this supplement can enhance overall brain health and well-being. Participants will take the supplement daily and complete assessments at various intervals to monitor changes. Individuals who are generally healthy, without major chronic conditions, and not currently taking other supplements are ideal candidates for this trial. As an unphased trial, participants can contribute to innovative research that may improve brain health and well-being.

Will I have to stop taking my current medications?

The trial requires that you stop taking any other supplements, but it does not specify about other medications. If you are taking supplements, you will need to stop them to participate.

What prior data suggests that this dietary supplement is safe?

Research shows that vitamins like B6, B12, and folate, along with curcumin, lemon balm, and American ginseng, are generally safe as dietary supplements. These ingredients often appear in health products and most people tolerate them well. However, dietary supplements are not regulated as strictly as regular foods and medicines, so they might not undergo as much safety testing.

While these supplements are usually safe, caution is wise. Some people might experience mild side effects, such as an upset stomach or allergic reactions. Additionally, not all supplements have been thoroughly tested for safety in certain groups, such as children or pregnant women.

For any concerns, consulting a healthcare professional before starting a new supplement is best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care options for brain health, which often include medications like acetylcholinesterase inhibitors or lifestyle changes such as diet and exercise, The Daily Supplement is unique because it focuses on enhancing brain health through a daily nutritional approach. This supplement is designed to target specific biomarkers associated with cognitive function, potentially providing quicker insights into its effectiveness. Researchers are excited about this treatment because it offers a non-invasive, easily accessible way to potentially improve brain health, with assessments showing results as early as seven days after starting the regimen.

What evidence suggests that The Daily Supplement might be an effective treatment for brain fog?

Research has shown that some dietary supplements can support overall health. For example, vitamins B6, B12, and folate play a crucial role in brain function. Curcumin, found in turmeric, may reduce inflammation and act as an antioxidant, potentially benefiting brain health. Lemon balm is sometimes used to enhance mood and cognitive skills, while American ginseng might improve mental clarity and focus. Although direct evidence for this specific combination of supplements is limited, each ingredient has been linked to potential brain health benefits. Participants in this trial will use "The Daily Supplement" to assess its effects on biomarkers and cognitive function. ^{6 7 8 9 10}

Who Is on the Research Team?

Christopher Hill, PhD

Principal Investigator

Citruslabs

Are You a Good Fit for This Trial?

Inclusion Criteria

In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a daily supplement and complete biomarker assessments and surveys at specified intervals

31 days

3 visits (in-person or virtual) at 1st dose, Day 7, Day 31

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The Daily Supplement

How Is the Trial Designed?

Group I: The Daily Supplement Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Parable

Lead Sponsor

Trials

1

Recruited

40+

Citruslabs

Industry Sponsor

Trials

94

Recruited

5,100+

Published Research Related to This Trial

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

Over a 20-year period, 1520 significant adverse drug event (ADE) case reports were analyzed, revealing that while key patient and drug variables were often reported, causality assessments were rarely included, with less than 1% of reports providing an objective evaluation.

The study suggests that medical journals should implement stricter guidelines for publishing ADE reports, including mandatory objective assessments of causality to enhance the reliability and usefulness of the information provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The quality of published adverse drug event reports. Kelly, WN.[2022]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

From 2006 to 2014, serious adverse drug events (ADEs) reported to the FDA increased two-fold, totaling 902,323 serious outcomes, including 244,408 deaths, indicating a growing concern for drug safety in real-world settings.

The majority of serious ADE reports came from health professionals (47.3%), with a significant number of reports among older adults (72.6% for ages 45 and above), highlighting the need for targeted monitoring and safety measures for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database. Sonawane, KB., Cheng, N., Hansen, RA.[2023]

A review of 175 oncology publications involving 96,125 patients revealed that the reporting of adverse events is often incomplete, with a median completeness score of only eight out of 14 possible elements based on CONSORT guidelines.

Most studies selectively reported adverse events, with 96% only including those above a certain severity threshold, and 88% grouping events of varying severity, highlighting the need for standardized reporting practices in oncology to improve clarity and consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in cancer clinical trial publications. Sivendran, S., Latif, A., McBride, RB., et al.[2022]

Citations

1. ods.od.nih.gov ods.od.nih.gov/factsheets/MVMS-HealthProfessional/

Multivitamin/mineral Supplements - Health Professional ... Multiple outcomes. Several studies have evaluated the link between MVM use and many different health outcomes, including cancer, heart disease, ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820369

Multivitamin Use and Mortality Risk in 3 Prospective US ... In this study, we investigated the hypothesis that daily MV use is associated with lower mortality risk among generally healthy US adults by ...

3. health.harvard.edu health.harvard.edu/newsletter_article/supplements-a-scorecard

Supplements: A scorecard - Harvard Health At present, only a few are likely to help, some may do more harm than good, and most will be little more than expensive disappointments.

4. examine.com examine.com/?srsltid=AfmBOopKHCqc2-1b8vECoyZc1We4_TbJn6XUJVQyz8ZQbyUz9sgBBU42

Examine: Evidence-based Analysis on Supplements & Nutrition Interventions like supplements and diets are evaluated based on measurable changes in specific outcomes like LDL and blood pressure. Conditions. Anxiety · ADHD ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11206876/

Quantity, Duration, Adherence, and Reasons for Dietary ... The primary reasons for dietary supplements intake included improving overall health (37.2%), maintaining health (34.7%), bone health (21.4%), and diet ...

6. ods.od.nih.gov ods.od.nih.gov/factsheets/list-all/

Dietary Supplement Fact Sheets Provides information about dietary supplements and their ingredients. These include vitamins, minerals, herbs and botanicals, probiotics, and more.

7. fda.gov fda.gov/food/dietary-supplements

Dietary Supplements FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products.

8. ods.od.nih.gov ods.od.nih.gov/factsheets/WYNTK-Consumer/

Dietary Supplements: What You Need to Know - Consumer Many supplements have not been well tested for safety in children and in women who are pregnant or nursing. If you think that you have had a bad ...

9. youtube.com youtube.com/watch?v=G8LG0OY3Izs

Supplements and Safety (full documentary) | Hidden Dangers ... In 2016, FRONTLINE, The New York Times and the Canadian Broadcasting Corporation examined the hidden dangers of vitamins and supplements, ...

10. ama-assn.org ama-assn.org/public-health/prevention-wellness/what-doctors-wish-patients-knew-about-vitamins-and-supplements

What doctors wish patients knew about vitamins and ... With more than 100,000 different supplements available, it is unclear what is safe to take. Three physicians aim to clear things up about ...