Primary outcomeMean· Baseline and after 15 days of supplement use
Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio
| Group | Value (Ratio) | Spread |
|---|---|---|
| Nicotinamide Riboside 2g/Day | 0.198 | 0.025 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataThe Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics
NCTNCT03151707 (opens ClinicalTrials.gov in a new tab)Other id2017P000006
This trial was stopped early.
Reason given at the registry: Lack of funding and appropriate staff
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
- Measures NAD+ (nicotinamide adenine dinucleotide), does not give it. It appears in an outcome measure.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 11 participants (actual)
- Sponsor
- Mclean Hospital · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 1 Oct 2017
- Primary completion
- 30 Sept 2022
- Completion
- 30 Sept 2022
- First posted
- 12 May 2017
- Last update posted
- 5 Mar 2024
- Conditions
- Healthy
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2017201820192020202120222023
- Ph 4Terminated
The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics
NCT031517071 Oct 2017 to 30 Sept 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary aim of this study is to investigate the effects of exogenously administered nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging. The secondary aims are to investigate the change in brain PCr/ATP and creatine kinase enzyme rate after NR use. In addition, NAD+/NADH ratio, PCr/ATP and CK enzyme rate will be measured in the calf muscle, as secondary outcome measures.
Interventions
- Nicotinamide RibosideDrug
Arms1
Experimental
Nicotinamide riboside 2g/day
Participants will receive NR at a dose of 2g/day
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio
Time frame · Baseline and after 15 days of supplement use
Registry description
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.
Secondary outcomes(5)
Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
Time frame · Baseline and after 15 days of supplement use
Registry description
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
Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate
Time frame · Baseline and after 15 days of supplement use
Registry description
Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy
Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio
Time frame · Baseline and after 15 days of supplement use
Registry description
Change from baseline to the end of treatment in calf muscle NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy
Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
Time frame · Baseline and after 15 days of supplement use
Registry description
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
Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate
Time frame · Baseline and after 15 days of supplement use
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcome· Baseline and after 15 days of supplement use
Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
| Group | Value |
|---|---|
| Nicotinamide Riboside 2g/Day | not posted |
Secondary outcome· Baseline and after 15 days of supplement use
Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate
| Group | Value |
|---|---|
| Nicotinamide Riboside 2g/Day | not posted |
Secondary outcome· Baseline and after 15 days of supplement use
Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio
| Group | Value |
|---|---|
| Nicotinamide Riboside 2g/Day | not posted |
Secondary outcome· Baseline and after 15 days of supplement use
Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP)
| Group | Value |
|---|---|
| Nicotinamide Riboside 2g/Day | not posted |
Secondary outcome· Baseline and after 15 days of supplement use
Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate
| Group | Value |
|---|---|
| Nicotinamide Riboside 2g/Day | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Nicotinamide Riboside 2g/DayParticipants will receive NR at a dose of 2g/day Nicotinamide Riboside: Nicotinamide riboside 2g/day for a 2 week duration | 0 / 11 | 0 / 11 | 3 / 11 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Age: 18-80 year-old
2. Male or female
3. Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID))
4. Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only.
Exclusion Criteria:
1. Significant medical or neurological illness.
2. Diagnosis diabetes mellitus (DM), uncontrolled hypertension (HTN), severe hypotension, coronary artery disease (CAD), metabolic syndrome, glaucoma, liver impairment, decreased renal function, respiratory disorders, uncontrolled peptic ulcer disease.
3. Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women
4. Pregnancy. Females of child-bearing age must be using an effective contraceptive method.
5. History of smoking, substance abuse or dependence.
6. Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal- containing intrauterine devices)
7. Medical condition that would prevent blood draws, including current anti-coagulant or anti-aggregant therapy, tendency for abnormal scarring (e.g. keloids).
8. Difficulty in swallowing capsules.
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