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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-16

Study Completion Date

2024-11-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nicotinamide Riboside Impact on Extracellular Nicotinamide Adenine Dinucleotide (NAD+)

NCT06005350

NAD

ACTIVE_NOT_RECRUITING NA

Impacts of Nicotinamide Riboside on Functional Capacity and Muscle Physiology in Older Veterans

NCT04691986

Sarcopenia Nicotinamide Adenine Dinucleotide Concentration Muscle Quality and NAD+ Content

RECRUITING NA

Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype

NCT02950441

Aging

UNKNOWN PHASE2

Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes

NCT02721537

Concussion, Mild

COMPLETED NA

A Study Investigating the Effects of Niagen™ in Healthy Adults.

NCT02712593

Bioavailability

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary Objective: To assess the effect of "NAD boosting" through NR intake in skeletal muscle and bone metabolism function, and biochemical evidence of improvement of DNA damage repair in healthy elderly female patients with and without exercise.

Secondary Objective: To assess the effect of NR in metabolic functions of glucose and lipid profile as well as to determine the safety of long term administration of NR in healthy elderly female patients with and without exercise.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Elderly Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nicotinamide Riboside

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.

Group Type ACTIVE_COMPARATOR

Nicotinamide Riboside

Intervention Type 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.

Placebo

Correspondent placebo, a pill not containing the active component.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotinamide Riboside

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
* Previous chronic kidney disease stages III and IV
* Malignancy
* Malabsorption syndrome
* Hypo- or Hyperparathyroidism
* Acromegaly
* Cushing's syndrome
* Hypopituitarism
* Severe chronic obstructive pulmonary disease
* Congestive heart failure
* Musculoskeletal disorder
* History of rheumatoid arthritis
* Previous gastric bypass surgery
* Clinical history of osteoporotic fracture (spine, hip, or distal forearm) within past year
* Extreme of BMI (≤ 18.5 kg/m2 or ≥ 40 kg/m2)

* History of methotrexate therapy
* History of denosumab therapy
* History of oral or inhaled corticosteroid use \> 3 months
* Current use of anticoagulants in general
* Anticonvulsant therapy (within previous year)
* Sodium fluoride (any history)
* Treatment within the past 3 years with bisphosphonates
* Treatment within the past 3 years with parathyroid hormone
* Treatment within the past 3 years with calcitonin
* Treatment within the past 3 years with estrogen
* Treatment within the past 3 years with selective estrogen receptor modulator

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes