Trial Outcomes & Findings for The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics (NCT NCT03151707)

NCT ID: NCT03151707

Last Updated: 2024-03-05

Results Overview

Change from baseline to the end of treatment in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy The NAD+/NADH ratio is calculated by first quantifying NAD+ and NADH separately in the data and then obtaining a simple ratio. There is a normative NAD+/NADH ratio range in healthy brain and deviations from this level in either direction can be a sign of pathology.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline and after 15 days of supplement use

Results posted on

2024-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotinamide Riboside 2g/Day Participants will receive NR at a dose of 2g/day Nicotinamide Riboside: Nicotinamide riboside 2g/day for a 2 week duration
Overall Study STARTED	11
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Nicotinamide Riboside 2g/Day Participants will receive NR at a dose of 2g/day Nicotinamide Riboside: Nicotinamide riboside 2g/day for a 2 week duration
Overall Study Lost to Follow-up	6

Baseline Characteristics

Early termination led to data not being available from all participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicotinamide Riboside 2g/Day n=11 Participants Participants will receive NR at a dose of 2g/day Nicotinamide Riboside: Nicotinamide riboside 2g/day for a 2 week duration
Age, Continuous	37.4 years STANDARD_DEVIATION 16.4 • n=11 Participants
Sex: Female, Male Female	4 Participants n=11 Participants
Sex: Female, Male Male	7 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants
Race (NIH/OMB) Asian	4 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	0 Participants n=11 Participants
Race (NIH/OMB) White	7 Participants n=11 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants
NAD+/NADH Ratio	3.75 Ratio STANDARD_DEVIATION 0.47 • n=4 Participants • Early termination led to data not being available from all participants

PRIMARY outcome

Timeframe: Baseline and after 15 days of supplement use

Population: Early termination led to small number of subjects analyzed

Change from baseline to the end of treatment in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy The NAD+/NADH ratio is calculated by first quantifying NAD+ and NADH separately in the data and then obtaining a simple ratio. There is a normative NAD+/NADH ratio range in healthy brain and deviations from this level in either direction can be a sign of pathology.

Outcome measures

Outcome measures
Measure	Nicotinamide Riboside 2g/Day n=4 Participants Participants will receive NR at a dose of 2g/day Nicotinamide Riboside: Nicotinamide riboside 2g/day for a 2 week duration
Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio	0.198 Ratio Standard Deviation 0.025

SECONDARY outcome

Timeframe: Baseline and after 15 days of supplement use

Population: No data were collected/analyzed for this measure.

Change from baseline to the end of treatment in brain phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio (PCr/ATP) as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and after 15 days of supplement use

Population: No data were collected/analyzed for this measure.

Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and after 15 days of supplement use

Population: No data were collected/analyzed for this measure.

Change from baseline to the end of treatment in calf muscle NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and after 15 days of supplement use

Population: No data were collected/analyzed for this measure.

Change from baseline to the end of treatment in calf muscle phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio (PCr/ATP) as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and after 15 days of supplement use

Population: No data were collected/analyzed for this measure.

Change from baseline to the end of treatment in calf muscle creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy

Outcome measures

Outcome data not reported

Adverse Events

Nicotinamide Riboside 2g/Day

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nicotinamide Riboside 2g/Day n=11 participants at risk Participants will receive NR at a dose of 2g/day Nicotinamide Riboside: Nicotinamide riboside 2g/day for a 2 week duration
Gastrointestinal disorders Mild Nausea	9.1% 1/11 • Number of events 1 • Up to 15 days
Gastrointestinal disorders Mild stomach pain	9.1% 1/11 • Number of events 1 • Up to 15 days
Skin and subcutaneous tissue disorders Bruising at blood draw site	9.1% 1/11 • Number of events 1 • Up to 15 days

Additional Information

Dost Ongur

McLean Hospital

Phone: 6178553922

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place