Cognitive FunctionNCT03562468
A Study by ChromaDex to Assess the Effects of TRU NIAGEN on Cognitive Function, Mood and Sleep in Older Adults
A study testing 300 mg/day of TRU NIAGEN (nicotinamide riboside) and 1000 mg/day of TRU NIAGEN (nicotinamide riboside) in people with Cognitive Function and Mood, run by ChromaDex, Inc. at 1 site in United States.
Trial summary
The sponsor of this study is ChromaDex, Inc. This is a double-blind, randomized, crossover study to investigate the effects of 300 mg/d and 1000 mg/d TRU NIAGEN (nicotinamide riboside) compared to a placebo control on cognitive function, mood and sleep in men and women over 55 years of age. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Mood, Sleep
- What is being tested?
- 300 mg/day of TRU NIAGEN (nicotinamide riboside) and 1000 mg/day of TRU NIAGEN (nicotinamide riboside)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is male or female, ≥55 years of age.
- Subject has a BMI of 18.50 to 34.99 kg/m2.
- Subject has a score of ≥80 on executive function at screening. One re-test will be allowed for subjects who require additional instruction on the CNS VS test battery.
- Subject is willing to maintain usual diet and physical activity patterns.
- Subject has no plans to change smoking habits during the study period.
- Subject is willing to limit alcohol consumption to no more than one serving of alcohol per day (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) and will abstain from consuming 2 h prior to retiring for the evening for the duration of the study.
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- Subject is willing to limit consumption of caffeine-containing beverages/foods/products to no more than 400 mg daily, with all caffeine consumption occurring prior to 6 pm.
- Subject is willing to fast (8 - 15 h, target 10 h, water only) prior to each clinic visit.
- Subject has no difficulties swallowing capsules.
- Subject is willing and able to attend all clinic visits.
- Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator and is willing to complete study procedures.
Who cannot join
- Individual has history or presence of a clinically significant (in the opinion of the Investigator) psychiatric disorder or neurologic disease including epilepsy, cerebrovascular disturbance or traumatic injury.
- Individual has a history of diagnosed clinical depression in the prior 2 years, or a score ≥20 (defined as moderate-to-severe depression) on the Beck Depression Inventory-II administered at visit 1 (week -1).
- Individual is currently diagnosed with dementia and/or has a score <24 on the Mini Mental State Questionnaire administered at visit 1 (week -1).
- Uncorrected abnormal vision that in the opinion of the Investigator would impair the subject's ability to complete the computerized testing (including but not limited to nearsightedness, farsightedness, and color blindness).
- Individual has a clinically important active endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic or biliary disorder.
- Individual has a history of a cardiovascular event or revascularization procedure within 6 months of visit 1 (week -1).
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- Individual has a diagnosis of type I diabetes mellitus. Type 2 diabetes mellitus is excluded if the individual has experienced initiation of or a dosage change in diabetes medication(s) within 2 months of visit 1 (week -1), or has significant co-morbidities as determined by the study physician.
- Insulin for the treatment of Type I or Type 2 diabetes mellitus is exclusionary.
- Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg).
- Individual has a recent history (prior 5 years) or the presence of cancer other than non-melanoma skin cancer.
- Individual has a history or presence of a chronic pain condition requiring regular use of opioid therapy.
- Individual has a recent history or strong potential for drug or alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1 ½ oz distilled spirits).
- Individual has a history of unconventional sleep patterns (e.g., night shift) or chronic insomnia (at least 3 d/week over the past month), a diagnosed sleep disorder, or a chronic medical condition with the potential to impact energy/fatigue levels.
- Individuals taking any form of niacin >25 mg/d and any use of nicotinamide riboside within 2 weeks of visit 1 (week -1).
- Individual is a heavy consumer of caffeinated beverages (>400 mg/d within 2 weeks of visit 1).
- Individual has a history of using psychotropic medications (including antidepressants and tranquilizers), stimulant medications, and/or narcotics within 4 weeks of visit 1 (week -1).
- Individual has used sleep aid medications, supplements, and/or products, including antihistamines, within 2 weeks of visit 1 (week -1) A washout prior to screening is allowed).
- Individual has a known allergy to any ingredients in the study products.
- Individual is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to use of a medically approved form of contraception throughout the study period.
- Subject has an active infection or has used antibiotics within 5 d of any clinic visit. For those with an active infection and/or using antibiotics, subjects must wait at least 5 d after the infection resolves or antibiotic use is complete. The test period will be extended for completion in these cases.
- Subject has been exposed to any non-registered drug product within 30 d of visit 1 (week -1).
- Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Crossover Study to Assess the Effects of Nicotinamide Riboside on Cognitive Function, Mood and Sleep in Older Adult Men and Women
The sponsor of this study is ChromaDex, Inc. This is a double-blind, randomized, crossover study to investigate the effects of 300 mg/d and 1000 mg/d TRU NIAGEN (nicotinamide riboside) compared to a placebo control on cognitive function, mood and sleep in men and women over 55 years of age. The trial is managed by Midwest Center for Metabolic and Cardiovascular Research.
- Conditions
- Cognitive Function, Mood, Sleep
- Being tested
- 300 mg/day of TRU NIAGEN (nicotinamide riboside), 1000 mg/day of TRU NIAGEN (nicotinamide riboside), Placebo
- Keywords
- Nicotinamide riboside, NAD, TRU NIAGEN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 mg/day of TRU NIAGEN (nicotinamide riboside)Dietary supplement
Also called Niagen, the active ingredient in TRU NIAGEN
Treatment with 300 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside).
1000 mg/day of TRU NIAGEN (nicotinamide riboside)Dietary supplement
Also called Niagen, the active ingredient in TRU NIAGEN
Treatment 1000 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside).
PlaceboDietary supplement
Treatment with placebo capsules will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Each subject will be randomly assigned to receive placebo for an 8-week treatment period. Subjects will be instructed to take two capsules (placebo) in the morning with breakfast and two capsules (placebo) in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. Receives: Dietary Supplement: Placebo |
| TRU NIAGEN (nicotinamide riboside) 300 mg/day | Experimental | Each subject will be randomly assigned to receive 300 mg/day of TRU NIAGEN (nicotinamide riboside) for an 8-week treatment period. Subjects will be instructed to take two capsules of TRU NIAGEN in the morning with breakfast and two capsules of TRU NIAGEN in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. Receives: Dietary Supplement: 300 mg/day of TRU NIAGEN (nicotinamide riboside) |
| TRU NIAGEN (nicotinamide riboside) 1000 mg/day | Experimental | Each subject will be randomly assigned to receive 1000 mg/day of TRU NIAGEN (nicotinamide riboside) for an 8-week treatment period. Subjects will be instructed to take two capsules of TRU NIAGEN in the morning with breakfast and two capsules of TRU NIAGEN in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. Receives: Dietary Supplement: 1000 mg/day of TRU NIAGEN (nicotinamide riboside) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary comparison will be the low dose (300 mg/d nicotinamide riboside) condition to the placebo condition for the change from baseline to the end of each relevant treatment period.
The primary outcome variable will be the difference between treatments in the change from baseline (defined as visit 2 value for each of the three treatment periods) in executive function measured with the CNS Vital Signs test battery, using the standard score.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start13 Jun 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Treatments will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChromaDex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Midwest Center for Metabolic and Cardiovascular Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562468
- Sponsor's protocol ID
- MB-1801
- Status last verified
- Jul 2019
- First submitted
- 25 May 2018
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover Study to Assess the Effects of Nicotinamide Riboside on Cognitive Function, Mood and Sleep in Older Adult Men and Women
- ClinicalTrials.gov ID
- NCT03562468
- Acronym / sponsor ID
- MB-1801
- Conditions
- Cognitive Function, Mood, Sleep
- Keywords
- Nicotinamide riboside, NAD, TRU NIAGEN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ChromaDex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Midwest Center for Metabolic and Cardiovascular Research
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sponsor of this study is ChromaDex, Inc. This is a double-blind, randomized, crossover study to investigate the effects of 300 mg/d and 1000 mg/d TRU NIAGEN (nicotinamide riboside) compared to a placebo control on cognitive function, mood and sleep in men and women over 55 years of age. The trial is managed by Midwest Center for Metabolic and Cardiovascular Research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Treatments will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach subject will be randomly assigned to receive placebo for an 8-week treatment period. Subjects will be instructed to take two capsules (placebo) in the morning with breakfast and two capsules (placebo) in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. |
| TRU NIAGEN (nicotinamide riboside) 300 mg/day | Experimental | Dietary Supplement: 300 mg/day of TRU NIAGEN (nicotinamide riboside)Each subject will be randomly assigned to receive 300 mg/day of TRU NIAGEN (nicotinamide riboside) for an 8-week treatment period. Subjects will be instructed to take two capsules of TRU NIAGEN in the morning with breakfast and two capsules of TRU NIAGEN in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. |
| TRU NIAGEN (nicotinamide riboside) 1000 mg/day | Experimental | Dietary Supplement: 1000 mg/day of TRU NIAGEN (nicotinamide riboside)Each subject will be randomly assigned to receive 1000 mg/day of TRU NIAGEN (nicotinamide riboside) for an 8-week treatment period. Subjects will be instructed to take two capsules of TRU NIAGEN in the morning with breakfast and two capsules of TRU NIAGEN in the evening with dinner. At the end of each 8-week treatment period subjects will crossover to the next treatment group until all three treatment periods have been completed at 24 weeks. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is male or female, ≥55 years of age.
- Subject has a BMI of 18.50 to 34.99 kg/m2.
- Subject has a score of ≥80 on executive function at screening. One re-test will be allowed for subjects who require additional instruction on the CNS VS test battery.
- Subject is willing to maintain usual diet and physical activity patterns.
- Subject has no plans to change smoking habits during the study period.
Key exclusion criteria (22 listed)
- Individual has history or presence of a clinically significant (in the opinion of the Investigator) psychiatric disorder or neurologic disease including epilepsy, cerebrovascular disturbance or traumatic injury.
- Individual has a history of diagnosed clinical depression in the prior 2 years, or a score ≥20 (defined as moderate-to-severe depression) on the Beck Depression Inventory-II administered at visit 1 (week -1).
- Individual is currently diagnosed with dementia and/or has a score <24 on the Mini Mental State Questionnaire administered at visit 1 (week -1).
- Uncorrected abnormal vision that in the opinion of the Investigator would impair the subject's ability to complete the computerized testing (including but not limited to nearsightedness, farsightedness, and color blindness).
- Individual has a clinically important active endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic or biliary disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 300 mg/day of TRU NIAGEN (nicotinamide riboside)Also: Niagen, the active ingredient in TRU NIAGENTreatment with 300 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside). | Dietary supplement | TRU NIAGEN (nicotinamide riboside) 300 mg/day |
| 1000 mg/day of TRU NIAGEN (nicotinamide riboside)Also: Niagen, the active ingredient in TRU NIAGENTreatment 1000 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside). | Dietary supplement | TRU NIAGEN (nicotinamide riboside) 1000 mg/day |
| PlaceboTreatment with placebo capsules will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside). | Dietary supplement | Placebo |
Primary outcome
The primary comparison will be the low dose (300 mg/d nicotinamide riboside) condition to the placebo condition for the change from baseline to the end of each relevant treatment period.
Time frame: 8 weeks
The primary outcome variable will be the difference between treatments in the change from baseline (defined as visit 2 value for each of the three treatment periods) in executive function measured with the CNS Vital Signs test battery, using the standard score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 300 mg/day of TRU NIAGEN (nicotinamide riboside) and 1000 mg/day of TRU NIAGEN (nicotinamide riboside) in people with Cognitive Function and Mood, run by ChromaDex, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary comparison will be the low dose (300 mg/d nicotinamide riboside) condition to the placebo condition for the change from baseline to the end of each relevant treatment period. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.