NAD-flux: Measurement of NAD+ Synthesis in Human Skeletal Muscle

Sponsor
AdventHealth Translational Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04905446
Collaborator
(none)
8
1
1
14.7
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Deuterated nicotinamide (D4-NAM) IV infusion
  • Procedure: Skeletal muscle biopsy
  • Procedure: Skin tissue biopsy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Measurement of NAD+ Synthesis in Human Skeletal Muscle
Actual Study Start Date :
Sep 10, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Healthy male subjects

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.

Procedure: Skin tissue biopsy
This procedure is used to sample skin tissue from the upper thigh via a punch biopsy.

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 AdventHealth Translational Research Institute Orlando Florida United States 32804

Sponsors and Collaborators

  • AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Stephen Gardell, PhD, Senior Investigator, Translational Research Institute, AdventHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AdventHealth Translational Research Institute
ClinicalTrials.gov Identifier:
NCT04905446
Other Study ID Numbers:
  • 1581811
First Posted:
May 27, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022