Your session is about to expire
← Back to Search
Nutraceutical
Deuterated Nicotinamide (D4-NAM) IV Infusion for Skeletal Muscle (NAD-flux Trial)
N/A
Waitlist Available
Led By Stephen Gardell, PhD
Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy male subjects between the ages of 21 to 40 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
NAD-flux Trial Summary
This trial is testing a new way to measure NAD synthesis in humans, which could help researchers understand how lifestyle choices, aging, and drugs impact this process.
Who is the study for?
Healthy men aged 21-40 with a BMI of 20-30 kg/m2 can join this study. They must understand and consent to the procedures, be able to follow the study schedule, and not have any medical conditions or take medications that could affect metabolism or are contraindicated.Check my eligibility
What is being tested?
The trial is testing how NAD synthesis in human skeletal muscle responds to lifestyle, aging, supplements, and drugs by using a heavy isotope derivative of nicotinamide (D4-NAM) given through IV infusion followed by biopsies.See study design
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, bruising from needle insertion for IV infusion and tissue sampling, as well as typical risks associated with local anesthesia like lidocaine.
NAD-flux Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy man aged between 21 and 40.
NAD-flux Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measurement of NAD+ mass isotopomers in extracts from human muscle and skin tissue biopsies as determined by liquid chromatography-mass spectrometry (LC-MS)
NAD-flux Trial Design
1Treatment groups
Experimental Treatment
Group I: Healthy male subjectsExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Skeletal muscle biopsy
2016
N/A
~70
Find a Location
Who is running the clinical trial?
Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,582 Total Patients Enrolled
AdventHealth Translational Research InstituteLead Sponsor
48 Previous Clinical Trials
20,166 Total Patients Enrolled
Stephen Gardell, PhDPrincipal InvestigatorSenior Investigator, Translational Research Institute, AdventHealth
1 Previous Clinical Trials
22 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes or pre-diabetes (HbA1c > 5.7).I am a healthy man aged between 21 and 40.I am taking aspirin or NSAIDs that cannot be stopped for the study.I have an ongoing infection.I have taken medication for high blood sugar.I have taken Tru Niagen, Basis, or similar NAD+ boosting supplements.I have a history of HIV, hepatitis B, or hepatitis C.I have low hemoglobin levels (<12 g/dl).I have a bleeding disorder.My kidney function is reduced with a GFR below 60.My blood pressure is not higher than 160/100 mmHg.I have not had major surgery in the last 3 months.I have bruising on my legs.I don't have serious health issues apart from untreated, minor seasonal allergies.I am on medication that can affect my blood sugar or muscle metabolism.
Research Study Groups:
This trial has the following groups:- Group 1: Healthy male subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical examination open to adults aged 18 or over?
"This clinical trial is seeking volunteers who are older than 21 and younger than 40 years of age."
Answered by AI
Are there any vacancies for participants in this clinical experimentation?
"Data hosted on clinicaltrials.gov suggests that this investigation is no longer recruiting participants; the initial posting was made September 10th 2021 and it had its final update February 1st 2023. Nevertheless, there are 6 other studies at present searching for volunteers."
Answered by AI
Is it possible to be enrolled in this clinical experiment?
"Eligible applicants must have skeletal muscle and be between 21 and 40 years old in order to qualify for this trial. Around 15 individuals will eventually join the study."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger