Benefits of Nicotinamide Riboside Upon Cognition and Sleep

NCT05500170 | Recruiting DMC

• 1 other identifier: FP00006694
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cognitive Impairment; Sleep Quality

Outcome Measures

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.

  Change from baseline to endpoint at 12 weeks

Secondary Outcomes (1)

• Cognitive function

  Change from baseline to endpoint at 12 weeks

Other Outcomes (1)

• Biomarkers

  Change from baseline to endpoint at 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention group will receive 500mg of NR twice daily

Dietary Supplement: Nicotinamide riboside

Placebo

PLACEBO COMPARATOR

Participants in the intervention group will receive 500mg of sham placebo twice daily

Dietary Supplement: Placebo

Interventions

Nicotinamide riboside DIETARY_SUPPLEMENT

Nicotinamide 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.

Also known as: NR, vitamin B3

Intervention

Placebo DIETARY_SUPPLEMENT

The placebo pill will contain micro cellulose powder.

Also known as: Placebo pill

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Sleep Quality. Pittsburgh Sleep Quality Index (PSQI) global score \>5

You may not qualify if:

• Dementia. Veteran Affairs - St. Louis University Mental Status questionnaire (VA-SLUMS) score \<20

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (3)

State University of New York at Buffalo

Buffalo, New York, 14203, United States

NOT YET RECRUITING

University at Buffalo State University of New York

Buffalo, New York, 14203, United States

NOT YET RECRUITING

Buffalo Veteran Affairs Medical Center

Buffalo, New York, 14215, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Initiation and Maintenance Disorders

Interventions

nicotinamide-beta-riboside; Niacinamide

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Carleara Weiss, PhD, MS, RN

CONTACT

7168282006; carleara@buffalo.edu

Rebecca A Lorenz, PhD, RN

CONTACT

716-829-2204; rlorenz@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study participants and investigators will be blinded to group assignment. A statistician will assign participants into groups and a pharmacist will distribute treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A clinical trial, randomized controlled trial, double-blinded. Participants will be assigned to intervention (NR supplementation) or placebo groups.

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 15, 2022
• Study Start: April 4, 2023
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Published or reported results from this trial will not contain any personal information that could be linked to individuals. De-identified data will be utilized for the publication of research findings in conferences, and scientific journals and will become available at the anticipated study completion (January 2025)
• Access Criteria: All information from data collection forms and clinical databases will be linked with the study identification number, and only deidentified data will be released and analyzed. All research files and consent forms will be stored in locked cabinets and rooms and will only be accessible to research personnel. All data files related to this project are located on a secure server with password-protected access.

Locations

US (3)