Status:
COMPLETED
Measurement of NAD+ Synthesis in Human Skeletal Muscle
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Skeletal Muscle
Eligibility:
MALE
21-40 years
Phase:
NA
Brief Summary
The key objective of this pilot research study is to dose human volunteers with a heavy (non-radioactive) isotope derivative of nicotinamide to detect NAD synthesis in human skeletal muscle. The ultim...
Eligibility Criteria
Inclusion
- Healthy male subjects who, at the time of screening are between the ages of 21 to 40 years of age, inclusive.
- BMI between 20-30 kg/m2 at the screening visit (SV)
- Understands the procedures and agrees to participate by giving written informed consent
- Willing and able to comply with the scheduled study day and other study procedures
Exclusion
- Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:
- History of type 1 or type 2 diabetes mellitus, including pre-diabetes (HbA1c \> 5.7)
- History of any antihyperglycemic agent (e.g., insulin)
- Currently taking medications that can alter glucose homeostasis (e.g., steroids, glucocorticoids, nicotinic acid) or skeletal muscle metabolism
- History of taking Tru Niagen, Basis (or any other NR-containing NAD+ booster) or niacin supplements.
- Any bleeding disorders
- Currently taking any aspirin (ASA) (including baby ASA) or NSAIDs (ibuprofen, naproxen, etc.) that cannot be safely stopped throughout the study. There is a recommended hold on NSAIDs and/or ASA for at least 2 days prior to biopsy, although not exclusionary
- Presence of bruising in lower extremities
- Any major surgery within the past 3 months
- Any acute or chronic infections
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological or allergic diseases, but excluding untreated, asymptomatic, seasonal allergies at the time of intervention.
- Previous difficulty with lidocaine or other local anesthetic agents
- Thyroid dysfunction (suppressed TSH, elevated TSH \<10 µIU/ml if symptomatic or elevated TSH \>10 µIU/ml if asymptomatic)
- Uncontrolled hypertension (BP \>160 mmHg systolic or \>100 mmHg diastolic)
- Use of tobacco or nicotine-containing products within the last 12 months.
- Chronic kidney disease with GFR of \< 60
- Anemia (hemoglobin \<12 g/dl) during screening
- History of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Liver function testing for ALT or AST greater than or equal to 2 times the upper limit of normal
- Participation in studies involving investigational drug(s) within 30 days prior to Screening visit
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening (participants may not donate blood any time during the study, through the final study day)
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days Labs may be repeated at the discretion of the PI, MI or Sub-investigators (Sub-I).
Key Trial Info
Start Date :
September 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04905446
Start Date
September 10 2021
End Date
December 20 2024
Last Update
March 13 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804