Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
- Conditions
- Healthy Elderly Volunteers
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Nicotinamide Riboside
- Registration Number
- NCT03818802
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 53
- Healthy elderly female subjects between 65 and 80 years of age
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Correspondent placebo, a pill not containing the active component. Nicotinamide Riboside 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.
- Primary Outcome Measures
Name Time Method 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
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.
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.
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
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.
- Secondary Outcome Measures
Name Time Method Glucose profile 6 months Serum glucose measure
Insulin 6 months Serum insulin measure
Hemoglobin A1C 6 months Hb A1C measure in blood sample
Lipid profile 6 months Blood cholesterol measure
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.
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States