Healthy Elderly Volunteers
Conditions
Keywords
NAD boosting therapy, Nicotinamide Riboside, NAD precursors, Aging
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.
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.
Interventions
DIETARY_SUPPLEMENTNicotinamide 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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy elderly female subjects between 65 and 80 years of age
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone metabolism | 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. |
| Skeletal muscle function | 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) | 6 months | The SPPB captures domains of strength, endurance, and balance and is highly predictive of subsequent disability. |
| Respiration rate on muscle biopsy samples | 6 months | The samples will be analyzed for respiration rate in isolated mitochondria and permeabilized fibers |
| PCR on muscle biopsy samples | 6 months | RT-PCR for gene expression |
| Immunoblot on muscle biopsy samples | 6 months | Immunoblot in skeletal lysates for protein expression |
| Maximal oxygen uptake (VO2 max) test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin | 6 months | Serum insulin measure |
| Lipid profile | 6 months | Blood cholesterol measure |
| Hemoglobin A1C | 6 months | Hb A1C measure in blood sample |
| Oral glucose tolerance test | 6 months | 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. |
| Glucose profile | 6 months | Serum glucose measure |
Countries
United States
Outcome results
None listed