An Exploratory Investigation of a Supplement to Promote Brain Health

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a mix of vitamins and natural substances to help people with brain fog, stress, and focus issues by supporting brain function.

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 data supports the effectiveness of the treatment The Daily Supplement?

Research shows that daily oral nutritional supplements can help improve clinical outcomes, such as reducing hospital readmissions and improving nutritional status, especially in older patients and those recovering from surgery. ^{1 2 3 4 5}

Is there any safety data available for The Daily Supplement?

The research articles provided do not contain specific safety data for The Daily Supplement or its other names. They discuss general methods for collecting safety data and reporting adverse drug events, but no specific information about this treatment is available. ^{6 7 8 9 10}

Research Team

Christopher Hill, PhD

Principal Investigator

Citruslabs

Eligibility Criteria

Inclusion Criteria

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

Timeline

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

Treatment Details

Interventions

• The Daily Supplement

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of oral nutritional supplementation on hospital outcomes. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Patient-important outcomes in randomized controlled trials in critically ill patients: a systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effect of unselected post-operative nutritional supplementation on nutritional status and clinical outcome of orthopaedic patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Prevention of malnutrition in older people during and after hospitalisation: results from a randomised controlled clinical trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Oral nutritional support of older (65 years+) medical and surgical patients after discharge from hospital: systematic review and meta-analysis of randomized controlled trials. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse event reporting in cancer clinical trial publications. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. [2019]