Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+)NCT03707652

Open-label Study to Assess Increasing Levels of NAD+(Nicotinamide Adenine Dinucleotide)

A study testing Oral supplement A, Oral supplement B and Oral supplement C in people with Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+), run by Supplement Formulators, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess an effective single oral supplement or combination of oral supplements for increasing whole blood NAD+ levels. Read more about this study

Who is it for?: Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+)
What is being tested?: Oral supplement A, Oral supplement B and Oral supplement C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2018to 24 May 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to provide written Informed Consent
Able to follow verbal and written study directions in English
Adult men and women between age 30-80 years (inclusive)
Women of reproductive potential will practice contraception during the Investigation
Body Mass Index (BMI) between 18.5 and 35 kg/m2
Must not be taking or be willing to stop taking any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.

Show all 11Show fewer

Must not be using or be willing to stop use of any "100%" or higher niacin fortified foods from seven days prior to screening visit and for the duration of the investigation
Able to maintain consistent diet and lifestyle habits throughout the study
Volunteers with chronic but stable and well controlled medical conditions (i.e., hypertension controlled by a consistent dose of medication for a minimum of six months; chronic use of consistent dose of blood-thinning medication; diet-controlled Type II diabetes) may participate at the discretion of the PI or Sub-I.
Willing and able to provide fasting blood samples
Able to attend scheduled visits at the Life Extension Clinical Research (LECR) facility

Who cannot join

Current use of prescription or over-the-counter nicotinic acid
Use of statin drugs
Having used any tobacco product or used a recreational drug in the past 6 months
Medically complicated [i.e., diabetes requiring insulin; uncontrolled hypertension (blood pressure readings at screening/baseline > 140 systolic or > 90 diastolic on two consecutive readings); etc.] at the discretion of the PI or Sub-I
Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the PI or Sub-I
Woman who is pregnant, nursing, or planning a pregnancy. Non-pregnant status of women of childbearing potential will be confirmed during each Day 3 Cycle LECR visit (Wednesday or Thursday) via serum pregnancy test.

Show all 10Show fewer

Currently, or within the past 30 days, enrolled in a different clinical investigation
Inability to provide a venous blood sample
Unable to refrain from any alcohol consumption for the duration of the study
Unable or unwilling to provide written informed consent for participation in study

Trial locations and contacts

1 site in 1 country.

United States1 site

Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, 33308

Other trials in United States

About this study

Official title: Three-Day Dosing NAD + Study

The purpose of this study is to assess an effective single oral supplement or combination of oral supplements for increasing whole blood NAD+ levels.

Read the detailed description

This is a open-label dose finding study to detect an effective single oral supplement or combination of oral supplements for enhancing whole blood levels of NAD+. Each subject will receive a specific dose of the formulation once daily for 3 days followed by a washout period. Upon completion of the treatment phase, there is a post-treatment period of assessments.

Participants receive assessments of blood tests, vital signs, body weight with completion of questionnaires.

The primary objective of the study is to identify the ideal dosage of an oral supplement to increase whole blood NAD+ levels in adults.

The secondary objective of the study is to monitor for safety from a change in fasting blood chemistry panel parameters after three day's dosing compared to cycle baseline.

Conditions: Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+)
Being tested: Oral supplement A, Oral supplement B, Oral supplement C, Oral supplement D, Oral Supplement D in combination with oral supplement C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral supplement ADietary supplement
Also called Vitamin B3 derivative
1, 2 or 4 capsules daily of oral supplement A for 3 days
Oral supplement BDietary supplement
Also called Vitamin B3 derivative
4 capsules daily of oral supplement B for 3 days
Oral supplement CDietary supplement
Also called Vitamin B3 derivative
1,2 or 4 capsules daily of oral supplement C for 3 days
Oral supplement DDietary supplement
Also called Vitamin B3 derivative
1 or 2 tablets daily of oral supplement D for 3 days
Oral Supplement D in combination with oral supplement CDietary supplement
1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days

Study groups in NCT03707652
Study group	Role	What they receive
Cohort A (oral supplement A)-2 capsules	Experimental	Oral supplement A (2 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement A
Cohort A (oral supplement B)-4 capsules	Experimental	Oral supplement B (4 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement B
Cohort A (oral supplement C)-2 capsules	Experimental	Oral supplement C (2 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement C
Cohort A (oral supplement A)-1 or 4 capsules	Experimental	Oral supplement A (1 or 4 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement A
Cohort A (oral supplement D)-1 or 2 tablets	Experimental	Oral supplement D (1 or 2 tablets) administered daily for 3 days Receives: Dietary Supplement: Oral supplement D
Cohort A (oral supplement D) or combination with supplement C	Experimental	Oral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement D; Dietary Supplement: Oral Supplement D in combination with oral supplement C
Cohort B (oral supplement B)-4 capsules	Experimental	Oral supplement B (4 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement B
Cohort B (oral supplement C)-2 capsules	Experimental	Oral supplement C (2 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement C
Cohort B (oral supplement A)-2 capsules	Experimental	Oral supplement A (2 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement A
Cohort B (oral supplement C)- 1 or 4 capsules	Experimental	Oral supplement C (1 or 4 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement C
Cohort B (oral supplement D)-1 or 2 tablets	Experimental	Oral supplement D (1 or 2 tablets) administered daily for 3 days Receives: Dietary Supplement: Oral supplement D
Cohort B(oral supplement D) or combination with supplement C	Experimental	Oral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days Receives: Dietary Supplement: Oral supplement D; Dietary Supplement: Oral Supplement D in combination with oral supplement C

What is being measured

The primary outcome is the main question the study is designed to answer.

Assess the mean change in NAD+ levels from baseline
Mean change in NAD+ levels
Measured: 63 days

Secondary outcomes (6)

Assess the mean change in AST (aspartate aminotransferase) levels from baseline
Mean change in AST level
Measured: 63 days
Assess the mean change in ALT (alanine aminotransferase) levels from baseline
Mean change in ALT level
Measured: 63 days
Assess the mean change in Total Cholesterol levels from baseline
Mean change in Total Cholesterol level
Measured: 63 days
Assess the mean change in Triglycerides levels from baseline
Mean change in Triglycerides level
Measured: 63 days
Assess the mean change in LDL Cholesterol levels from baseline
Mean change in LDL Cholesterol level
Measured: 63 days
Assess the mean change in HDL Cholesterol levels from baseline
Mean change in HDL Cholesterol level
Measured: 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 201824 May 2018

First posted16 Oct 2018
Study start12 Mar 2018
Primary completion16 May 2018
Study completion24 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03707652
Sponsor's protocol ID: CL094
Status last verified: May 2018
First submitted: 11 Oct 2018
Last updated: 18 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kennedy BK, Berger SL, Brunet A, Campisi J, Cuervo AM, Epel ES, Franceschi C, Lithgow GJ, Morimoto RI, Pessin JE, Rando TA, Richardson A, Schadt EE, Wyss-Coray T, Sierra F. Geroscience: linking aging to chronic disease. Cell. 2014 Nov 6;159(4):709-13. doi: 10.1016/j.cell.2014.10.039.
PubMed 25417146
Massudi H, Grant R, Braidy N, Guest J, Farnsworth B, Guillemin GJ. Age-associated changes in oxidative stress and NAD+ metabolism in human tissue. PLoS One. 2012;7(7):e42357. doi: 10.1371/journal.pone.0042357. Epub 2012 Jul 27.
PubMed 22848760
Verdin E. NAD(+) in aging, metabolism, and neurodegeneration. Science. 2015 Dec 4;350(6265):1208-13. doi: 10.1126/science.aac4854.
PubMed 26785480
Revollo JR, Grimm AA, Imai S. The regulation of nicotinamide adenine dinucleotide biosynthesis by Nampt/PBEF/visfatin in mammals. Curr Opin Gastroenterol. 2007 Mar;23(2):164-70. doi: 10.1097/MOG.0b013e32801b3c8f.
PubMed 17268245
Yang H, Lavu S, Sinclair DA. Nampt/PBEF/Visfatin: a regulator of mammalian health and longevity? Exp Gerontol. 2006 Aug;41(8):718-26. doi: 10.1016/j.exger.2006.06.003. Epub 2006 Jul 13.
PubMed 16842957
Gross CJ, Henderson LM. Digestion and absorption of NAD by the small intestine of the rat. J Nutr. 1983 Feb;113(2):412-20. doi: 10.1093/jn/113.2.412.
PubMed 6218262
Knip M, Douek IF, Moore WP, Gillmor HA, McLean AE, Bingley PJ, Gale EA; European Nicotinamide Diabetes Intervention Trial Group. Safety of high-dose nicotinamide: a review. Diabetologia. 2000 Nov;43(11):1337-45. doi: 10.1007/s001250051536.
PubMed 11126400
Airhart SE, Shireman LM, Risler LJ, Anderson GD, Nagana Gowda GA, Raftery D, Tian R, Shen DD, O'Brien KD. An open-label, non-randomized study of the pharmacokinetics of the nutritional supplement nicotinamide riboside (NR) and its effects on blood NAD+ levels in healthy volunteers. PLoS One. 2017 Dec 6;12(12):e0186459. doi: 10.1371/journal.pone.0186459. eCollection 2017.
PubMed 29211728
Dellinger RW, Santos SR, Morris M, Evans M, Alminana D, Guarente L, Marcotulli E. Repeat dose NRPT (nicotinamide riboside and pterostilbene) increases NAD+ levels in humans safely and sustainably: a randomized, double-blind, placebo-controlled study. NPJ Aging Mech Dis. 2017 Nov 24;3:17. doi: 10.1038/s41514-017-0016-9. eCollection 2017.
PubMed 29184669
Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.
PubMed 27721479
de Picciotto NE, Gano LB, Johnson LC, Martens CR, Sindler AL, Mills KF, Imai S, Seals DR. Nicotinamide mononucleotide supplementation reverses vascular dysfunction and oxidative stress with aging in mice. Aging Cell. 2016 Jun;15(3):522-30. doi: 10.1111/acel.12461. Epub 2016 Mar 11.
PubMed 26970090
Mills KF, Yoshida S, Stein LR, Grozio A, Kubota S, Sasaki Y, Redpath P, Migaud ME, Apte RS, Uchida K, Yoshino J, Imai SI. Long-Term Administration of Nicotinamide Mononucleotide Mitigates Age-Associated Physiological Decline in Mice. Cell Metab. 2016 Dec 13;24(6):795-806. doi: 10.1016/j.cmet.2016.09.013. Epub 2016 Oct 27.
PubMed 28068222
ClinicalTrials.gov. Effect of
Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington (DC): National Academies Press (US); 1998. Available from http://www.ncbi.nlm.nih.gov/books/NBK114310/
PubMed 23193625

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Three-Day Dosing NAD + Study
ClinicalTrials.gov ID: NCT03707652
Acronym / sponsor ID: CL094
Conditions: Increase in Blood Levels of Nicotinamide Adenine Dinucleotide (NAD+)
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Supplement Formulators, Inc.Industry (pharma, biotech, devices)
Study start: 12 Mar 2018 (actual)
Primary completion: 16 May 2018 (actual)
Study completion: 24 May 2018 (actual)
First posted: 16 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess an effective single oral supplement or combination of oral supplements for increasing whole blood NAD+ levels.

Detailed description

Participants receive assessments of blood tests, vital signs, body weight with completion of questionnaires.

The primary objective of the study is to identify the ideal dosage of an oral supplement to increase whole blood NAD+ levels in adults.

The secondary objective of the study is to monitor for safety from a change in fasting blood chemistry panel parameters after three day's dosing compared to cycle baseline.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
Cohort A (oral supplement A)-2 capsules	Experimental	Dietary Supplement: Oral supplement AOral supplement A (2 capsules) administered daily for 3 days
Cohort A (oral supplement B)-4 capsules	Experimental	Dietary Supplement: Oral supplement BOral supplement B (4 capsules) administered daily for 3 days
Cohort A (oral supplement C)-2 capsules	Experimental	Dietary Supplement: Oral supplement COral supplement C (2 capsules) administered daily for 3 days
Cohort A (oral supplement A)-1 or 4 capsules	Experimental	Dietary Supplement: Oral supplement AOral supplement A (1 or 4 capsules) administered daily for 3 days
Cohort A (oral supplement D)-1 or 2 tablets	Experimental	Dietary Supplement: Oral supplement DOral supplement D (1 or 2 tablets) administered daily for 3 days
Cohort A (oral supplement D) or combination with supplement C	Experimental	Dietary Supplement: Oral supplement D, Dietary Supplement: Oral Supplement D in combination with oral supplement COral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days
Cohort B (oral supplement B)-4 capsules	Experimental	Dietary Supplement: Oral supplement BOral supplement B (4 capsules) administered daily for 3 days
Cohort B (oral supplement C)-2 capsules	Experimental	Dietary Supplement: Oral supplement COral supplement C (2 capsules) administered daily for 3 days
Cohort B (oral supplement A)-2 capsules	Experimental	Dietary Supplement: Oral supplement AOral supplement A (2 capsules) administered daily for 3 days
Cohort B (oral supplement C)- 1 or 4 capsules	Experimental	Dietary Supplement: Oral supplement COral supplement C (1 or 4 capsules) administered daily for 3 days
Cohort B (oral supplement D)-1 or 2 tablets	Experimental	Dietary Supplement: Oral supplement DOral supplement D (1 or 2 tablets) administered daily for 3 days
Cohort B(oral supplement D) or combination with supplement C	Experimental	Dietary Supplement: Oral supplement D, Dietary Supplement: Oral Supplement D in combination with oral supplement COral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Able to provide written Informed Consent
Able to follow verbal and written study directions in English
Adult men and women between age 30-80 years (inclusive)
Women of reproductive potential will practice contraception during the Investigation
Body Mass Index (BMI) between 18.5 and 35 kg/m2

Key exclusion criteria (10 listed)

Current use of prescription or over-the-counter nicotinic acid
Use of statin drugs
Having used any tobacco product or used a recreational drug in the past 6 months
Medically complicated [i.e., diabetes requiring insulin; uncontrolled hypertension (blood pressure readings at screening/baseline > 140 systolic or > 90 diastolic on two consecutive readings); etc.] at the discretion of the PI or Sub-I
Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the PI or Sub-I

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral supplement AAlso: Vitamin B3 derivative1, 2 or 4 capsules daily of oral supplement A for 3 days	Dietary supplement	Cohort A (oral supplement A)-1 or 4 capsules, Cohort A (oral supplement A)-2 capsules, Cohort B (oral supplement A)-2 capsules
Oral supplement BAlso: Vitamin B3 derivative4 capsules daily of oral supplement B for 3 days	Dietary supplement	Cohort A (oral supplement B)-4 capsules, Cohort B (oral supplement B)-4 capsules
Oral supplement CAlso: Vitamin B3 derivative1,2 or 4 capsules daily of oral supplement C for 3 days	Dietary supplement	Cohort A (oral supplement C)-2 capsules, Cohort B (oral supplement C)- 1 or 4 capsules, Cohort B (oral supplement C)-2 capsules
Oral supplement DAlso: Vitamin B3 derivative1 or 2 tablets daily of oral supplement D for 3 days	Dietary supplement	Cohort A (oral supplement D) or combination with supplement C, Cohort A (oral supplement D)-1 or 2 tablets, Cohort B (oral supplement D)-1 or 2 tablets, Cohort B(oral supplement D) or combination with supplement C
Oral Supplement D in combination with oral supplement C1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days	Dietary supplement	Cohort A (oral supplement D) or combination with supplement C, Cohort B(oral supplement D) or combination with supplement C

Primary outcome

Assess the mean change in NAD+ levels from baseline
Time frame: 63 days
Mean change in NAD+ levels

6 secondary outcomes

Assess the mean change in AST (aspartate aminotransferase) levels from baseline
Time frame: 63 days
Assess the mean change in ALT (alanine aminotransferase) levels from baseline
Time frame: 63 days
Assess the mean change in Total Cholesterol levels from baseline
Time frame: 63 days
Assess the mean change in Triglycerides levels from baseline
Time frame: 63 days
Assess the mean change in LDL Cholesterol levels from baseline
Time frame: 63 days
Assess the mean change in HDL Cholesterol levels from baseline
Time frame: 63 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Background: PubMed 25417146Kennedy BK, Berger SL, Brunet A, Campisi J, Cuervo AM, Epel ES, Franceschi C, Lithgow GJ, Morimoto RI, Pessin JE, Rando TA, Richardson A, Schadt EE, Wyss-Coray T, Sierra F. Geroscience: linking aging to chronic disease. Cell. 2014 Nov 6;159(4):709-13. doi: 10.1016/j.cell.2014.10.039.
Background: PubMed 22848760Massudi H, Grant R, Braidy N, Guest J, Farnsworth B, Guillemin GJ. Age-associated changes in oxidative stress and NAD+ metabolism in human tissue. PLoS One. 2012;7(7):e42357. doi: 10.1371/journal.pone.0042357. Epub 2012 Jul 27.
Background: PubMed 26785480Verdin E. NAD(+) in aging, metabolism, and neurodegeneration. Science. 2015 Dec 4;350(6265):1208-13. doi: 10.1126/science.aac4854.
Background: PubMed 17268245Revollo JR, Grimm AA, Imai S. The regulation of nicotinamide adenine dinucleotide biosynthesis by Nampt/PBEF/visfatin in mammals. Curr Opin Gastroenterol. 2007 Mar;23(2):164-70. doi: 10.1097/MOG.0b013e32801b3c8f.
Background: PubMed 16842957Yang H, Lavu S, Sinclair DA. Nampt/PBEF/Visfatin: a regulator of mammalian health and longevity? Exp Gerontol. 2006 Aug;41(8):718-26. doi: 10.1016/j.exger.2006.06.003. Epub 2006 Jul 13.
Background: PubMed 6218262Gross CJ, Henderson LM. Digestion and absorption of NAD by the small intestine of the rat. J Nutr. 1983 Feb;113(2):412-20. doi: 10.1093/jn/113.2.412.
Background: PubMed 11126400Knip M, Douek IF, Moore WP, Gillmor HA, McLean AE, Bingley PJ, Gale EA; European Nicotinamide Diabetes Intervention Trial Group. Safety of high-dose nicotinamide: a review. Diabetologia. 2000 Nov;43(11):1337-45. doi: 10.1007/s001250051536.
Background: PubMed 29211728Airhart SE, Shireman LM, Risler LJ, Anderson GD, Nagana Gowda GA, Raftery D, Tian R, Shen DD, O'Brien KD. An open-label, non-randomized study of the pharmacokinetics of the nutritional supplement nicotinamide riboside (NR) and its effects on blood NAD+ levels in healthy volunteers. PLoS One. 2017 Dec 6;12(12):e0186459. doi: 10.1371/journal.pone.0186459. eCollection 2017.
Background: PubMed 29184669Dellinger RW, Santos SR, Morris M, Evans M, Alminana D, Guarente L, Marcotulli E. Repeat dose NRPT (nicotinamide riboside and pterostilbene) increases NAD+ levels in humans safely and sustainably: a randomized, double-blind, placebo-controlled study. NPJ Aging Mech Dis. 2017 Nov 24;3:17. doi: 10.1038/s41514-017-0016-9. eCollection 2017.
Background: PubMed 27721479Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948.
Background: PubMed 26970090de Picciotto NE, Gano LB, Johnson LC, Martens CR, Sindler AL, Mills KF, Imai S, Seals DR. Nicotinamide mononucleotide supplementation reverses vascular dysfunction and oxidative stress with aging in mice. Aging Cell. 2016 Jun;15(3):522-30. doi: 10.1111/acel.12461. Epub 2016 Mar 11.
Background: PubMed 28068222Mills KF, Yoshida S, Stein LR, Grozio A, Kubota S, Sasaki Y, Redpath P, Migaud ME, Apte RS, Uchida K, Yoshino J, Imai SI. Long-Term Administration of Nicotinamide Mononucleotide Mitigates Age-Associated Physiological Decline in Mice. Cell Metab. 2016 Dec 13;24(6):795-806. doi: 10.1016/j.cmet.2016.09.013. Epub 2016 Oct 27.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Swick, Ph.D principal investigator

LIfe Extension

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the mean change in NAD+ levels from baseline (time frame: 63 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03707652, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.