Healthy Elderly VolunteersNCT03818802
Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
A study testing Nicotinamide Riboside in people with Healthy Elderly Volunteers, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Volunteers
- What is being tested?
- Nicotinamide Riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 8 Nov 2024
- 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 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy elderly female subjects between 65 and 80 years of age
Who cannot join
- General 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
Show all 44Show fewer
- Laboratory Exclusion Criteria
- 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)
- Clinical History Exclusion Criteria
- 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)
- Medication Exclusion Criteria
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
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.
Read the detailed description
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
- Healthy Elderly Volunteers
- Being tested
- Nicotinamide Riboside, Placebo
- Keywords
- NAD boosting therapy, Nicotinamide Riboside, NAD precursors, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Nicotinamide Riboside |
| Placebo | Placebo comparator | Correspondent placebo, a pill not containing the active component. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Short Physical Performance Battery (SPPB)
The SPPB captures domains of strength, endurance, and balance and is highly predictive of subsequent disability.
Measured: 6 months
Respiration rate on muscle biopsy samples
The samples will be analyzed for respiration rate in isolated mitochondria and permeabilized fibers
Measured: 6 months
PCR on muscle biopsy samples
RT-PCR for gene expression
Measured: 6 months
Immunoblot on muscle biopsy samples
Immunoblot in skeletal lysates for protein expression
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
Glucose profile
Serum glucose measure
Measured: 6 months
Insulin
Serum insulin measure
Measured: 6 months
Lipid profile
Blood cholesterol measure
Measured: 6 months
Hemoglobin A1C
Hb A1C measure in blood sample
Measured: 6 months
Oral glucose tolerance test
An 18-gauge cannula will be inserted in a retrograde fashion into a dorsal hand vein of the non-dominant arm. The hand will be placed in a heated box (55°C) to enable sampling of arterialized venous blood. Blood will be drawn at 0 (baseline), 10, 20, 30, 60, 90, and 120 minutes for the measurement of glucose, insulin, and C-peptide concentrations. After the baseline blood draw, subjects will ingest 75 g of glucose over a period of 5 minutes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start16 Sep 2019
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly VolunteersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo N. Chini, Mayo Clinic
- Investigators
- Eduardo N Chini, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818802
- Sponsor's protocol ID
- 18-000224
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2019
- Last updated
- 26 Feb 2025
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
- ClinicalTrials.gov ID
- NCT03818802
- Acronym / sponsor ID
- 18-000224
- Conditions
- Healthy Elderly Volunteers
- Keywords
- NAD boosting therapy, Nicotinamide Riboside, NAD precursors, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 28 Jan 2019 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide Riboside | Active comparator | Dietary Supplement: Nicotinamide RibosideNR 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCorrespondent placebo, a pill not containing the active component. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy elderly female subjects between 65 and 80 years of age
Key exclusion criteria (44 listed)
- General Exclusion Criteria
- Laboratory Exclusion Criteria
- Clinical History Exclusion Criteria
- Medication Exclusion Criteria
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 |
|---|---|---|
| Nicotinamide RibosideIt 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. | Dietary supplement | Nicotinamide Riboside |
| PlaceboIt 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. | Dietary supplement | Placebo |
Primary outcome
Maximal oxygen uptake (VO2 max) test
Time frame: 6 months
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.
Skeletal muscle function
Time frame: 6 months
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.
Short Physical Performance Battery (SPPB)
Time frame: 6 months
The SPPB captures domains of strength, endurance, and balance and is highly predictive of subsequent disability.
Respiration rate on muscle biopsy samples
Time frame: 6 months
The samples will be analyzed for respiration rate in isolated mitochondria and permeabilized fibers
PCR on muscle biopsy samples
Time frame: 6 months
RT-PCR for gene expression
Immunoblot on muscle biopsy samples
Time frame: 6 months
Immunoblot in skeletal lysates for protein expression
Bone metabolism
Time frame: 6 months
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.
5 secondary outcomes
Glucose profile
Time frame: 6 months
Insulin
Time frame: 6 months
Lipid profile
Time frame: 6 months
Hemoglobin A1C
Time frame: 6 months
Oral glucose tolerance test
Time frame: 6 months
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 26 Feb 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Elderly Volunteers
Recruiting
Intervention Program for Psychological Well-Being in Institutionalized Older Adults Through Virtual Reality
Healthy Volunteers, Aging, Healthy
Not yet recruiting
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
RecruitingPhase 1
A Phase I Study in Healthy Volunteers and Parkinson's Disease (PD) Patients.
Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease
Not yet recruiting
Milk Free From A1-Type β-Casein With Human Milk Oligosaccharides on Gut Health, Immunity, Cognitive Development, and Temperament in Toddlers
Healthy Volunteers
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.
Eduardo N Chini, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside in people with Healthy Elderly Volunteers, run by Mayo Clinic 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 1 inclusion and 44 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 26 Feb 2025. 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?
Maximal oxygen uptake (VO2 max) test (time frame: 6 months). The study lists 7 primary outcomes in all. 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 26 Feb 2025.