Clinical trial NCT03818802: Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Elderly Volunteers
Keywords: NAD boosting therapy
Nicotinamide Riboside
NAD precursors
Aging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 53
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Healthy elderly female subjects between 65 and 80 years of age

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maximal oxygen uptake (VO2 max) test
timeFrame: 6 months
measure: Skeletal muscle function
timeFrame: 6 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: 6 months
measure: Respiration rate on muscle biopsy samples
timeFrame: 6 months
measure: PCR on muscle biopsy samples
timeFrame: 6 months
measure: Immunoblot on muscle biopsy samples
timeFrame: 6 months
measure: Bone metabolism
timeFrame: 6 months
Secondary outcomes:
measure: Glucose profile
timeFrame: 6 months
measure: Insulin
timeFrame: 6 months
measure: Lipid profile
timeFrame: 6 months
measure: Hemoglobin A1C
timeFrame: 6 months
measure: Oral glucose tolerance test
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eduardo N Chini, MD
role: PRINCIPAL_INVESTIGATOR
References: