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

NCT03707652 | Completed

• 1 other identifier: CL094
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Assess the mean change in NAD+ levels from baseline

  Mean change in NAD+ levels

  63 days

Secondary Outcomes (6)

• Assess the mean change in AST (aspartate aminotransferase) levels from baseline

  63 days

• Assess the mean change in ALT (alanine aminotransferase) levels from baseline

  63 days

• Assess the mean change in Total Cholesterol levels from baseline

  63 days

• Assess the mean change in Triglycerides levels from baseline

  63 days

• Assess the mean change in LDL Cholesterol levels from baseline

  63 days

Study Arms (12)

Cohort A (oral supplement A)-2 capsules

EXPERIMENTAL

Oral supplement A (2 capsules) administered daily for 3 days

Dietary Supplement: Oral supplement A

Cohort A (oral supplement B)-4 capsules

EXPERIMENTAL

Oral supplement B (4 capsules) administered daily for 3 days

Dietary Supplement: Oral supplement B

Cohort A (oral supplement C)-2 capsules

EXPERIMENTAL

Oral supplement C (2 capsules) administered daily for 3 days

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

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

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

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

Dietary Supplement: Oral supplement B

Cohort B (oral supplement C)-2 capsules

EXPERIMENTAL

Oral supplement C (2 capsules) administered daily for 3 days

Dietary Supplement: Oral supplement C

Cohort B (oral supplement A)-2 capsules

EXPERIMENTAL

Oral supplement A (2 capsules) administered daily for 3 days

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

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

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

Dietary Supplement: Oral supplement D; Dietary Supplement: Oral Supplement D in combination with oral supplement C

Interventions

Oral supplement A DIETARY_SUPPLEMENT

1, 2 or 4 capsules daily of oral supplement A for 3 days

Also known as: Vitamin B3 derivative

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 B DIETARY_SUPPLEMENT

4 capsules daily of oral supplement B for 3 days

Also known as: Vitamin B3 derivative

Cohort A (oral supplement B)-4 capsules; Cohort B (oral supplement B)-4 capsules

Oral supplement C DIETARY_SUPPLEMENT

1,2 or 4 capsules daily of oral supplement C for 3 days

Also known as: Vitamin B3 derivative

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 D DIETARY_SUPPLEMENT

1 or 2 tablets daily of oral supplement D for 3 days

Also known as: Vitamin B3 derivative

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 C DIETARY_SUPPLEMENT

1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days

Cohort A (oral supplement D) or combination with supplement C; Cohort B(oral supplement D) or combination with supplement C

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Supplement Formulators, Inc.: lead

Study Sites (1)

Life Extension Clinical Research, Inc.

Fort Lauderdale, Florida, 33308, United States

Location

Related Publications (14)

• 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.

  PMID: 25417146 BACKGROUND

• 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.

  PMID: 22848760 BACKGROUND

• Verdin E. NAD(+) in aging, metabolism, and neurodegeneration. Science. 2015 Dec 4;350(6265):1208-13. doi: 10.1126/science.aac4854.

  PMID: 26785480 BACKGROUND

• 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.

  PMID: 17268245 BACKGROUND

• 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.

  PMID: 16842957 BACKGROUND

• 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.

  PMID: 6218262 BACKGROUND

• 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.

  PMID: 11126400 BACKGROUND

• 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.

  PMID: 29211728 BACKGROUND

• 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.

  PMID: 29184669 BACKGROUND

• 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.

  PMID: 27721479 BACKGROUND

• 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.

  PMID: 26970090 BACKGROUND

• 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.

  PMID: 28068222 BACKGROUND

• ClinicalTrials.gov. Effect of

  BACKGROUND

• 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/

  PMID: 23193625 BACKGROUND

Study Officials

• Andrew Swick, Ph.D

  LIfe Extension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: March 12, 2018
• Primary Completion: May 16, 2018
• Study Completion: May 24, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)