Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging

NCT03818802 | Completed

• 1 other identifier: 18-000224
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to determine if the vitamin B3 derivative Nicotinamide Riboside (NR) has any effects in bone, skeletal muscle, and metabolic functions and structure in aging.

Conditions

Healthy Elderly Volunteers

Keywords

NAD boosting therapy; Nicotinamide Riboside; NAD precursors; Aging

Outcome Measures

Primary Outcomes (7)

• Maximal oxygen uptake (VO2 max) test

  Maximal oxygen uptake (VO2 max) test measures the maximum rate of oxygen consumption during incremental exercise (exercise of increasing intensity) and reflects the cardiorespiratory fitness of an individual and is an important determinant of their endurance capacity during prolonged exercise.

  6 months

• Skeletal muscle function

  The 6-minute walk test (6MWT) quantifies the distance a person can walk in six minutes and will be used to document the mobility/functional status of a patient. Originally developed to evaluate the physical capacity of patients with cardiopulmonary diseases, the test has been used to assess treatment effects, physical function status, and to predict morbidity and mortality in several patient populations including frail older adults.

  6 months

• Short Physical Performance Battery (SPPB)

  The SPPB captures domains of strength, endurance, and balance and is highly predictive of subsequent disability.

  6 months

• Respiration rate on muscle biopsy samples

  The samples will be analyzed for respiration rate in isolated mitochondria and permeabilized fibers

  6 months

• PCR on muscle biopsy samples

  RT-PCR for gene expression

  6 months

• Immunoblot on muscle biopsy samples

  Immunoblot in skeletal lysates for protein expression

  6 months

• Bone metabolism

  Serum Carboxy-terminal Telopeptide (CTX), tartrate-resistant acid phosphatase isoform type 5b (TRAP5b), Amino-terminal Pro-peptide (P1NP), and osteocalcin will all be measured to monitor bone turnover markers.

  6 months

Secondary Outcomes (5)

• Glucose profile

  6 months

• Insulin

  6 months

• Lipid profile

  6 months

• Hemoglobin A1C

  6 months

• Oral glucose tolerance test

  6 months

Study Arms (2)

Nicotinamide Riboside

ACTIVE COMPARATOR

NR is a single chemical moiety containing nicotinamide and ribose. The investigational product is a synthetic NR that is nature-identical to naturally-occurring NR, does not induce flushing or pruritus and has no effect on lipid levels.

Dietary Supplement: Nicotinamide Riboside

Placebo

PLACEBO COMPARATOR

Correspondent placebo, a pill not containing the active component.

Dietary Supplement: Placebo

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

It will be administered a total of 1000 mg/day of NR in a regimen of 500mg every 12 hours by mouth for 4.5 months. After 4.5 months, an advanced individual training (AIT) will be implemented in addition to administration of 1000mg/day (500mg every 12 hours) for 6 weeks more, completing total of 6 months.

Nicotinamide Riboside

Placebo DIETARY_SUPPLEMENT

It will be administered a correspondent placebo with the same shape and color as the active pill 12 hours by mouth for 4.5 months. After 4.5 months, an advanced individual training (AIT) will be implemented in addition to administration of correspondent placebo every 12 hours for 6 weeks more, completing total of 6 months.

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy elderly female subjects between 65 and 80 years of age

You may not qualify if:

• Subjects who participate in regular structured exercise more than 2 hours and 30 min per week or 1hour and 15 min of vigorous exercise per week.
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent by the patient
• Subject who takes multivitamins containing vitamin B3 derivatives in a dose \> 200 mg/day
• Participation in another investigational drug study within 1 year of treatment
• Serum 25-hydroxyvitamin D \< 15 ng/ml
• Serum phosphorus \> 5 mg/dL
• Serum alkaline phosphatase 50% above normal limit
• Serum aspartate transaminase 50% above normal limit
• Serum calcium \> 10.5 mg/dL
• Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min Creatinine Clearance \< 50%
• Poorly controlled Diabetes Mellitus (HbA1c\>8)
• Confirmed diagnosis of Diabetes Mellitus in use of insulin
• Subjects presenting systolic BP\>180 mmHg or a diastolic BP\>90 mmHg on initial evaluation
• Previous diagnosis of liver disease

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Officials

• Eduardo N Chini, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This protocol will employ a blinded design so that the participant, study personnel, and investigators will not know subject group assignment status. The unblinding would be done by contacting the research pharmacy. While the safety of the subject always comes first, it is still important to seriously consider if unmasking/unblinding the study therapy is necessary to ensure a subject's safety. The unmasking/unblinding will happen only when there is a serious adverse event; in this case this event will be logged in the specific Case Report Form for Serious Adverse Event (SAE) that is part of this protocol. However, in cases where unmasking/unblinding was not associated with an SAE, such actions will be reported in a same timeline requirements for reporting of SAEs.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators will enroll 48 subjects (24 placebo vs. 24 NR) considering a dropout rate of 20%. Patients will be screened at outpatient clinic visit by the research team before the enrollment. For those subjects interested and qualified it will be offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin treatment and followed for 4.5 months. After 4.5 months, a structured exercise regimen will be implemented in addition to the NR/placebo treatment and the patients will be followed for 6 weeks more, completing 6 months.

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: September 16, 2019
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: February 26, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)