Effects of Vitamin B3 Derivative Nicotinamide Riboside (NR) in Bone, Skeletal Muscle and Metabolic Functions in Aging
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|ClinicalTrials.gov Identifier: NCT03818802|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Elderly Volunteers||Dietary Supplement: Nicotinamide Riboside Dietary Supplement: Placebo||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||This protocol will employ a blinded design so that the participant, study personnel, and investigators will not know subject group assignment status. The unblinding would be done by contacting the research pharmacy. While the safety of the subject always comes first, it is still important to seriously consider if unmasking/unblinding the study therapy is necessary to ensure a subject's safety. The unmasking/unblinding will happen only when there is a serious adverse event; in this case this event will be logged in the specific Case Report Form for Serious Adverse Event (SAE) that is part of this protocol. However, in cases where unmasking/unblinding was not associated with an SAE, such actions will be reported in a same timeline requirements for reporting of SAEs.|
|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|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2021|
Active Comparator: 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.
Dietary Supplement: Nicotinamide Riboside
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.
Placebo Comparator: Placebo
Correspondent placebo, a pill not containing the active component.
Dietary Supplement: Placebo
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.
- Maximal oxygen uptake (VO2 max) test [ Time Frame: 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 [ Time Frame: 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.
- Short Physical Performance Battery (SPPB) [ Time Frame: 6 months ]The SPPB captures domains of strength, endurance, and balance and is highly predictive of subsequent disability.
- Respiration rate on muscle biopsy samples [ Time Frame: 6 months ]The samples will be analyzed for respiration rate in isolated mitochondria and permeabilized fibers
- PCR on muscle biopsy samples [ Time Frame: 6 months ]RT-PCR for gene expression
- Immunoblot on muscle biopsy samples [ Time Frame: 6 months ]Immunoblot in skeletal lysates for protein expression
- Bone metabolism [ Time Frame: 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.
- Glucose profile [ Time Frame: 6 months ]Serum glucose measure
- Insulin [ Time Frame: 6 months ]Serum insulin measure
- Lipid profile [ Time Frame: 6 months ]Blood cholesterol measure
- Hemoglobin A1C [ Time Frame: 6 months ]Hb A1C measure in blood sample
- Oral glucose tolerance test [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818802
|Contact: Karina S Kanamori Mendes, MD||507-266-2173||Mendes.Karina@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Karina S Kanamori Mendes, MD 507-266-2173 firstname.lastname@example.org|
|Contact: Christine K Suby, RN 507-422-0746 email@example.com|
|Principal Investigator:||Eduardo N Chini, MD||Mayo Clinic|