Measurement of NAD+ Synthesis in Human Skeletal Muscle

NCT04905446 | Completed

• 1 other identifier: 1581811
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Skeletal Muscle

Outcome Measures

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)

  4 weeks

Study Arms (1)

Healthy male subjects

OTHER

Other: Deuterated nicotinamide (D4-NAM) IV infusion; Procedure: Skeletal muscle biopsy; Procedure: Skin tissue biopsy

Interventions

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.

Healthy male subjects

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.

Healthy male subjects

Skin tissue biopsy PROCEDURE

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

Healthy male subjects

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Stephen Gardell, PhD

  Senior Investigator, Translational Research Institute, AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 27, 2021
• Study Start: September 10, 2021
• Primary Completion: June 14, 2022
• Study Completion: December 20, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)