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Lack of funding and appropriate staff
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide riboside 2g/day | Experimental | Participants will receive NR at a dose of 2g/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide Riboside | Drug | Nicotinamide riboside 2g/day for a 2 week duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio | 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. | Baseline and after 15 days of supplement use |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP) | 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 | Baseline and after 15 days of supplement use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dost Ongur, MD PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio | 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. | Early termination led to small number of subjects analyzed | Posted | Mean | Standard Deviation | Ratio | Baseline and after 15 days of supplement use |
|
Up to 15 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Nausea | Gastrointestinal disorders | Systematic Assessment |
Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dost Ongur | McLean Hospital | 6178553922 | dongur@partners.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2016 | Feb 6, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
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| Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate | Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy | Baseline and after 15 days of supplement use |
| Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio | Change from baseline to the end of treatment in calf muscle NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy | 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) | 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 | Baseline and after 15 days of supplement use |
| Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate | 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 | Baseline and after 15 days of supplement use |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| NAD+/NADH Ratio | NAD+/NADH ratio is calculated by first quantifying NAD+ and NADH separately in MR Spectroscopy data and then obtaining a simple ratio of the 2 measures. There is a normative ratio in healthy brain and deviations from this ratio in either direction can be a sign of pathology. | Early termination led to data not being available from all participants | Mean | Standard Deviation | Ratio |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP) | 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 | No data were collected/analyzed for this measure. | Posted | Baseline and after 15 days of supplement use |
|
|
| Secondary | Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate | Change from baseline to the end of treatment in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy | No data were collected/analyzed for this measure. | Posted | Baseline and after 15 days of supplement use |
|
|
| Secondary | Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio | Change from baseline to the end of treatment in calf muscle NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy | No data were collected/analyzed for this measure. | Posted | Baseline and after 15 days of supplement use |
|
|
| Secondary | Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP) | 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 | No data were collected/analyzed for this measure. | Posted | Baseline and after 15 days of supplement use |
|
|
| Secondary | Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate | 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 | No data were collected/analyzed for this measure. | Posted | Baseline and after 15 days of supplement use |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| Mild stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Bruising at blood draw site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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