Measurement of NAD+ Synthesis in Human Skeletal Muscle

Skeletal Muscle Clinical Trial

— NAD-flux  

Official title:

Measurement of NAD+ Synthesis in Human Skeletal Muscle

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04905446
• Other study ID #: 1581811
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ultimate goal is to examine the impact of lifestyle choices, aging, nutraceuticals, and drugs on the rate of NAD synthesis in human subjects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: June 2024
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Healthy male subjects who, at the time of screening are between the ages of 21 to 40 years of age, inclusive.

2. BMI between 20-30 kg/m2 at the screening visit (SV)

3. Understands the procedures and agrees to participate by giving written informed consent

4. Willing and able to comply with the scheduled study day and other study procedures

Exclusion Criteria:

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:

1. History of type 1 or type 2 diabetes mellitus, including pre-diabetes (HbA1c > 5.7)

2. History of any antihyperglycemic agent (e.g., insulin)

3. Currently taking medications that can alter glucose homeostasis (e.g., steroids, glucocorticoids, nicotinic acid) or skeletal muscle metabolism

4. History of taking Tru Niagen, Basis (or any other NR-containing NAD+ booster) or niacin supplements.

5. Any bleeding disorders

6. 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

7. Presence of bruising in lower extremities

8. Any major surgery within the past 3 months

9. Any acute or chronic infections

10. 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.

11. Previous difficulty with lidocaine or other local anesthetic agents

12. Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)

13. Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)

14. Use of tobacco or nicotine-containing products within the last 12 months.

15. Chronic kidney disease with GFR of < 60

16. Anemia (hemoglobin <12 g/dl) during screening

17. History of human immunodeficiency virus (HIV), hepatitis B or hepatitis C

18. Liver function testing for ALT or AST greater than or equal to 2 times the upper limit of normal

19. Participation in studies involving investigational drug(s) within 30 days prior to Screening visit

20. 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)

21. 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).

Related Conditions & MeSH terms

• Skeletal Muscle

Intervention

Other:
• Deuterated nicotinamide (D4-NAM) IV infusion
Nicotinamide adenine dinucleotide (NAD) is a vitally important substance that is found in all cells of the body. D4-NAM (in normal saline) will be infused via an indwelling catheter.The IV infusion will continue for 8 hrs.

Procedure:
• Skeletal muscle biopsy
Participants will have a muscle biopsy performed on the muscle in the thigh. We will collect a small sample of blood before the biopsy. This procedure is used to sample muscle cells from the right or left leg Vastus Lateralis (thigh) muscle.
• Skin tissue biopsy
This procedure is used to sample skin tissue from the upper thigh via a punch biopsy.

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS)		4 weeks