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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
53
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.
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.
Mayo Clinic
Rochester, Minnesota, United States
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.
Time frame: 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.
Time frame: 6 months
Short Physical Performance Battery (SPPB)
The SPPB captures domains of strength, endurance, and balance and is highly predictive of subsequent disability.
Time frame: 6 months
Respiration rate on muscle biopsy samples
The samples will be analyzed for respiration rate in isolated mitochondria and permeabilized fibers
Time frame: 6 months
PCR on muscle biopsy samples
RT-PCR for gene expression
Time frame: 6 months
Immunoblot on muscle biopsy samples
Immunoblot in skeletal lysates for protein expression
Time frame: 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.
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Time frame: 6 months
Glucose profile
Serum glucose measure
Time frame: 6 months
Insulin
Serum insulin measure
Time frame: 6 months
Lipid profile
Blood cholesterol measure
Time frame: 6 months
Hemoglobin A1C
Hb A1C measure in blood sample
Time frame: 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.
Time frame: 6 months