- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06579209
NAD+ Oral Supplement Pilot Intervention in Adult Females
The goal of this clinical trial is to learn whether Nicotinamide adenine dinucleotide (NAD+) can influence cognition and biomarkers in healthy, cognitively intact women aged 40-80. The main questions it aims to answer are:
Will cognitive functioning change in response to NAD+? Will inflammatory markers and serum indicators of neurodegeneration change in response to NAD+? Researchers will compare individuals receiving NAD+ to those receiving placebo to see if the results differ.
Participants will:
Complete an online questionnaire, Visit the lab for computerized cognitive testing and a blood draw, Take NAD+ or a placebo every day for 4 weeks, Visit the lab for computerized cognitive testing and a blood draw
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Kingston, Rhode Island, United States, 02881
- University of Rhode Island
-
Pawtucket, Rhode Island, United States, 02860
- Independence Square, University of Rhode Island
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identify as Female
- Have a BMI of 18.5 or above
- Must be able to swallow tablets
Exclusion Criteria:
- Those who are pregnant, breastfeeding, or taking hormone medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-testing prior to intervention
Prior to receiving the supplement, either Nicotinamide adenine dinucleotide or the placebo, participants will undergo cognitive testing and a blood draw.
|
|
|
No Intervention: Post-testing after intervention
After receiving the supplement, either Nicotinamide adenine dinucleotide or the placebo, participants will undergo cognitive testing and a blood draw.
|
|
|
Experimental: Intervention
For four weeks, the participant will consume an oral supplement, either Nicotinamide adenine dinucleotide or a placebo.
|
Participants will take a supplement for four weeks.
The supplement will either be Nicotinamide adenine dinucleotide or a placebo.
Other Names:
Participants will take a supplement for four weeks.
The supplement will either be Nicotinamide adenine dinucleotide or a placebo pill.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurocognition
Time Frame: four weeks
|
NIH Toolkit Cognition Battery, Automated Neuropsychological Assessment Metrics
|
four weeks
|
|
Neurodegenerative disease panel
Time Frame: four weeks
|
BDNF, Cathespin D, MPO, PAI-1 (total), PDGF-AA, PDGF-AB/BB, RANTES, slCAM-1, sNCAM, sVCAM-1
|
four weeks
|
|
Markers of systemic inflammation
Time Frame: four weeks
|
GM-CSF, IFNγ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A, IL-23, TNFα
|
four weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Inflammation
- Neurodegenerative Diseases
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Nucleic Acids, Nucleotides, and Nucleosides
- Enzymes and Coenzymes
- Purines
- Coenzymes
- Ribonucleotides
- Nucleotides
- Adenine Nucleotides
- Purine Nucleotides
- Therapeutics
- NAD
Other Study ID Numbers
- 2087241-4
- P20GM103430 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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