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History of Changes for Study: NCT03562468
A Study to Assess the Effects of Nicotinamide Riboside on Cognitive Function, Mood and Sleep in Older Adults
Latest version (submitted July 23, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 8, 2018 None (earliest Version on record)
2 June 19, 2018 Study Description and Study Status
3 June 22, 2018 Sponsor/Collaborators, Study Identification, Study Description and Study Status
4 July 27, 2018 Arms and Interventions, Study Status, Outcome Measures, Eligibility, Study Design, Conditions, Study Description and Study Identification
5 November 9, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 February 15, 2019 Study Status
7 July 23, 2019 Recruitment Status and Study Status
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Study NCT03562468
Submitted Date:  June 8, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: MB-1801
Brief Title: A Study to Assess the Effects of Nicotinamide Riboside on Cognitive Function, Mood and Sleep in Older Adults
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2018
Overall Status: Recruiting
Study Start: June 2018
Primary Completion: March 2019 [Anticipated]
Study Completion: March 2019 [Anticipated]
First Submitted: May 25, 2018
First Submitted that
Met QC Criteria:
June 8, 2018
First Posted: June 19, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
June 8, 2018
Last Update Posted: June 19, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Midwest Center for Metabolic and Cardiovascular Research
Responsible Party: Sponsor
Collaborators: ChromaDex, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is a double-blind, randomized, crossover study to investigate the effects of 300 mg/d and 1000 mg/d NR (Niagen) compared to a placebo control on cognitive function, mood and sleep in men and women over 55 years of age. The study will consist of one screening visit (visit 1, week -1), one baseline visit (visit 2, week 0) and two treatment visits during each of three 8-week treatment periods (visits 3 and 4, weeks 4 and 8; visits 5 and 6, weeks 12 and 16; and visit 7 and 8, weeks 20 and 24).
Detailed Description:

At visit 1 (week -1), subjects will provide informed consent and undergo screening procedures including medical history, measurements of height, body weight, body mass index (BMI), resting heart rate and blood pressure, evaluation of prior/current medication/supplement use and inclusion/exclusion criteria. Resting heart rate and blood pressure will be measured three times, each separated by 1 minute, after the subject has been resting quietly for 5 minutes. This procedure will be followed throughout the study. A blood draw will be performed for a chemistry profile and hematology. The Beck Depression Inventory, Memory Assessment Complaint Questionnaire (MAC-Q), and the Mini Mental State Examination (MMSE) (Appendices 2, 3, 4) will be administered to determine eligibility for participation in the study. In addition, subjects will complete a practice test of the CNS Vital Signs cognitive test battery (Appendix 5). Eligible subjects will be provided study instructions for the baseline visit (visit 2, week 0).

At visits 3, 5, and 7 subjects will return to the clinic fasting (8-15 h, target 10 h, water only) and clinic visit procedures including measurement of resting heart rate and blood pressure, body weight, evaluation of prior/current medication/supplement use, and evaluation of inclusion/exclusion criteria will be completed. A blood draw will be performed for NAD+ and related metabolites and a blood sample will be archived for back-up and possible future analysis of non-genetic metabolic parameters. Following the blood draw, subjects will be provided with a standardized breakfast (t = 0 min) within a 30-min timeframe of the recorded breakfast provided at visit 2 (week 0). Subjects will have 20 min to consume the breakfast in its entirety. The assigned study product will be taken with the breakfast meal. At t = 30 min, subjects will complete the CNS Vital Signs Test Battery, PSQI, Leeds and POMS Questionnaires. Vital signs (heart rate and blood pressure) will be assessed. Subjects will be queried for adverse events (AEs) and study product will be collected and compliance assessed. Study product will be dispensed and study instructions will be reviewed.

At visits 2, 4, 6, and 8 subjects will return to the clinic fasting (8-15 h, target 10 h, water only) and clinic visit procedures including measurement of resting heart rate and blood pressure, weight, evaluation of prior/current medication/supplement use, and evaluation of inclusion/exclusion criteria will be completed. A blood draw will be performed for a chemistry profile, hematology and NAD+ and related metabolites and a blood sample will be archived for back-up and possible future analysis of non-genetic metabolic parameters. Following the blood draw, subjects will be provided with a standardized breakfast (t = 0 min) within a 30-min timeframe of the recorded breakfast provided at baseline visit (visit 2; week 0). The assigned study product will be taken with the breakfast meal. Subjects will have 20 min to consume the breakfast in its entirety. At t = 30 min, subjects will complete the CNS Vital Signs Test Battery, PSQI, and the Leeds and POMS Questionnaires. Vital signs (heart rate and blood pressure) will be assessed and subjects will complete the retinal metabolic analysis scan. AEs will be assessed, study product will be collected, and compliance will be assessed. Subjects will then cross over to the next treatment sequence. Study product will be dispensed at visits 2, 4, and 6 only.

Open or close this module Conditions
Conditions: Cognitive Function
Mood
Sleep
Keywords: Nicotinamide riboside
NAD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
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.
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo
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.
Dietary Supplement: Placebo
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 nicotinamide riboside (Niagen) and 1000 mg/d nicotinamide riboside (Niagen).
Experimental: Nicotinamide riboside 300 mg/day
Each subject will be randomly assigned to receive 300 mg/day of nicotinamide riboside (NR) for an 8-week treatment period. Subjects will be instructed to take two capsules of NR in the morning with breakfast and two capsules of NR 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.
Dietary Supplement: 300 mg/day of nicotinamide riboside
Treatment with 300 mg/day of 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 nicotinamide riboside (Niagen) and 1000 mg/d nicotinamide riboside (Niagen).
Other Names:
  • Niagen, the active ingredient in TRU NIAGEN
Experimental: Nicotinamide riboside 1000 mg/day
Each subject will be randomly assigned to receive 1000 mg/day of nicotinamide riboside (NR) for an 8-week treatment period. Subjects will be instructed to take two capsules of NR in the morning with breakfast and two capsules of NR 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.
Dietary Supplement: 1000 mg/day of nicotinamide riboside
Treatment 1000 mg/day of 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 nicotinamide riboside (Niagen) and 1000 mg/d nicotinamide riboside (Niagen).
Other Names:
  • Niagen, the active ingredient in TRU NIAGEN
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The primary outcome variable will be the difference between the 300 mg NR condition and placebo in the change from baseline in executive function measured with the CNS Vital Signs test battery.
[ Time Frame: 8 weeks ]

The executive function measured with the CNS Vital Signs test battery after the 8-week treatment period with nicotinamide riboside (300mg/day) will be compared with baseline. The executive function measured with the CNS Vital Signs test battery after the 8-week treatment period with placebo will be compared with baseline. The primary outcome variable will be the difference between treatments in the change from baseline in executive function measured with the CNS Vital Signs test battery.
Open or close this module Eligibility
Minimum Age: 55 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. Subject is male or female, ≥55 years of age.
  2. Subject has a BMI of 18.50 to 34.99 kg/m2.
  3. Subject has a score >25 on the MAC-Q administered at visit 1 (week -1).
  4. Subject has a score of ≥80 on executive function at screening.
  5. Subject is willing to maintain usual diet and physical activity patterns.
  6. Subject has no plans to change smoking habits during the study period.
  7. 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.
  8. Subject is willing to limit consumption of caffeine-containing beverages/foods/products to no more than 400 mg daily, with that consumption occurring prior to 6 pm.
  9. Subject is willing to fast (8 - 15 h, target 10 h, water only) prior to each clinic visit.
  10. Subject has no difficulties swallowing capsules.
  11. Subject is willing and able to attend all clinic visits.
  12. 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.

Exclusion Criteria:

  1. Individual has history or presence of a clinically diagnosed psychiatric disorder or neurologic disease including epilepsy, cerebrovascular disturbance or traumatic injury.
  2. 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 administered at visit 1 (week -1).
  3. Individual is currently diagnosed with dementia and/or has a score <26 on the Mini Mental State Questionnaire administered at visit 1 (week -1).
  4. Individual has a clinically important endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic or biliary disorder.
  5. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg).
  6. Individual has a recent history (prior 5 years) or the presence of cancer other than non-melanoma skin cancer.
  7. Individual has a history or presence of a chronic pain condition requiring regular use of opioid therapy.
  8. 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).
  9. 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.
  10. Individuals taking any form of niacin >100 mg/d and any use of nicotinamide riboside within 2 weeks of visit 1 (week -1).
  11. Individual is a heavy consumer of caffeinated beverages (>400 mg/d within 2 weeks of visit 1).
  12. 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).
  13. 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).
  14. Individual has a known allergy to any ingredients in the study products.
  15. 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.
  16. 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.
  17. Subject has been exposed to any non-registered drug product within 30 d of visit 1 (week -1).
  18. 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.
Open or close this module Contacts/Locations
Central Contact Person: Kevin Maki, PhD
Telephone: 630-469-6600
Email: kmaki@mbclinicalresearch.com
Central Contact Backup: Melissa Ashe, MS
Telephone: 561-757-5766
Email: mashe@mbclinicalresearch.com
Locations: United States, Florida
MB Clinical Research
[Recruiting]
Boca Raton, Florida, United States, 33487
Contact:Contact: Moneka Ali, BA 561-757-5766 mkhan@mbclinicalresearch.com
Contact:Contact: Melissa Ashe, MS 561-757-5766 mashe@mbclinicalresearch.com
Contact:Principal Investigator: Mary Anne Buggia, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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