Status:
COMPLETED
Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
Lead Sponsor:
Mayo Clinic
Conditions:
Healthy Elderly Volunteers
Eligibility:
FEMALE
65-80 years
Phase:
NA
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 eld...
Eligibility Criteria
Inclusion
- Healthy elderly female subjects between 65 and 80 years of age
Exclusion
- 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
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03818802
Start Date
September 16 2019
End Date
November 8 2024
Last Update
February 26 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905