A Study by ChromaDex to Assess the Effects of TRU NIAGEN on Cognitive Function, Mood and Sleep in Older Adults

NCT03562468 | Completed

• 1 other identifier: MB-1801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. The trial is managed by Midwest Center for Metabolic and Cardiovascular Research.

Conditions

Cognitive Function; Mood; Sleep

Keywords

Nicotinamide riboside; NAD; TRU NIAGEN

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (3)

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.

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.

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.

Dietary Supplement: 1000 mg/day of TRU NIAGEN (nicotinamide riboside)

Interventions

300 mg/day of TRU NIAGEN (nicotinamide riboside) DIETARY_SUPPLEMENT

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).

Also known as: Niagen, the active ingredient in TRU NIAGEN

TRU NIAGEN (nicotinamide riboside) 300 mg/day

1000 mg/day of TRU NIAGEN (nicotinamide riboside) DIETARY_SUPPLEMENT

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).

Also known as: Niagen, the active ingredient in TRU NIAGEN

TRU NIAGEN (nicotinamide riboside) 1000 mg/day

Placebo DIETARY_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).

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.
• 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).

Sponsors & Collaborators

• ChromaDex, Inc.: lead
• Midwest Center for Metabolic and Cardiovascular Research: collaborator

Study Sites (1)

MB Clinical Research

Boca Raton, Florida, 33487, United States

Location

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study site will be provided placebo and TRU NIAGEN capsules, each labeled with the protocol number, blinded product code, expiration date, batch number, the statement "For Investigational Use Only" and a space to write the subject's initials, screen and date dispensed.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 19, 2018
• Study Start: June 13, 2018
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)