Benefits of Nicotinamide Riboside Upon Cognition and Sleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorState University of New York at Buffalo
About this trial
Poor sleep quality and short sleep duration may be a mechanistic component of cognitive impairment in older adults, associated with a decline in brain-derived neurotrophic factor. Increasing the availability of nicotinamide adenine dinucleotide (NAD+) with supplementation of its precursor, nicotinamide riboside (NR), a form of vitamin B3 may increase the expression of brain-derived neurotrophic factor. This study proposes to examine the benefits of NR supplementation on sleep and cognitive function in older adults with comprehensive subjective and objective measures and to explore its impacts on serum brain-derived neurotrophic factor.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Sleep Quality. Pittsburgh Sleep Quality Index (PSQI) global score >5
Disqualifiers
Dementia. Veteran Affairs - St. Louis University Mental Status questionnaire (VA-SLUMS) score <20
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotinamide riboside
Dietary supplementNicotinamide riboside (NR) is a form of vitamin B3, which is found in fruits, vegetables, meat, and milk. NR is converted into nicotinamide adenosine dinucleotide NAD+. Low NAD+ levels have been linked to Alzheimer's disease and sleep disturbances.
Placebo
Dietary supplementThe placebo pill will contain micro cellulose powder.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Quality Assessment
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index , where global score \>5 indicates poor sleep quality and global score \<5 indicates good sleep quality.
Time frame
Change from baseline to endpoint at 12 weeksSecondary outcomes
1
Cognitive function
Cognitive function will be assessed with the Veterans Affairs St. Louis University Mental Health Status (VA-SLUMS), which contains 11 items designed to measure orientation, memory, attention, and executive function. Scores range from 0-30 with categories of unimpaired, mildly impaired, and impaired.
Time frame
Change from baseline to endpoint at 12 weeksOther outcomes
1
Biomarkers
Assessment of serum levels of BDNF, NfL, Aβ42/Aβ40 ratio, and p-tau as potential markers of cognition and sleep
Time frame
Change from baseline to endpoint at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov