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Completed

NCT Number: NCT04905446

Measurement of NAD+ Synthesis in Human Skeletal Muscle

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.

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Key information

Conditions

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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:

  • 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).

Treatment and study plan

Deuterated nicotinamide (D4-NAM) IV infusion

Other

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.

Skeletal muscle biopsy

Procedure

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

Procedure

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

Primary outcomes

  1. Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Acronym: NAD-flux

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
May 27, 2021
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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