Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging

Mayo Clinic

Status: Completed

Conditions: Healthy Elderly Volunteers

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Nicotinamide Riboside

Study type: Interventional

Funder types: Other

Identifiers

NCT03818802

18-000224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: Female

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups, including a placebo group

Nicotinamide Riboside

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nicotinamide Riboside

Placebo

Placebo Comparator group

Description:

Correspondent placebo, a pill not containing the active component.

Treatment:

Dietary Supplement: Placebo