NCT03707652|Completed
Open-label Study to Assess Increasing Levels of NAD+(Nicotinamide Adenine Dinucleotide)
Three-Day Dosing NAD + Study
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Three-Day Dosing NAD + Study
Sponsor study identifier
interventional
8
1 country
1
Study Start
March 12, 2018
Actual (reported)Primary Completion
May 16, 2018
Actual (reported)Study Completion
May 24, 2018
Actual (reported)The purpose of this study is to assess an effective single oral supplement or combination of oral supplements for increasing whole blood NAD+ levels.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 24, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2018
Actual (reported)May 16, 2018
Actual (reported)May 24, 2018
Actual (reported)October 11, 2018
Actual (reported)October 16, 2018
Actual (reported)Assess the mean change in NAD+ levels from baseline
Mean change in NAD+ levels
63 days
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
Oral supplement A (2 capsules) administered daily for 3 days
Oral supplement B (4 capsules) administered daily for 3 days
Oral supplement C (2 capsules) administered daily for 3 days
1, 2 or 4 capsules daily of oral supplement A for 3 days
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, 33308, United States
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.
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.
Andrew Swick, Ph.D
LIfe Extension
8 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2018
First Posted
October 16, 2018
Study Start
March 12, 2018
Actual (reported)Oral supplement A (1 or 4 capsules) administered daily for 3 days
Oral supplement D (1 or 2 tablets) administered daily for 3 days
Oral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days
Oral supplement B (4 capsules) administered daily for 3 days
Oral supplement C (2 capsules) administered daily for 3 days
Oral supplement A (2 capsules) administered daily for 3 days
Oral supplement C (1 or 4 capsules) administered daily for 3 days
Oral supplement D (1 or 2 tablets) administered daily for 3 days
Oral supplement D (1 or 2 tablets) or combination with oral supplement C (2 or 4 capsules) administered daily for 3 days
4 capsules daily of oral supplement B for 3 days
1,2 or 4 capsules daily of oral supplement C for 3 days
1 or 2 tablets daily of oral supplement D for 3 days
1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Verdin E. NAD(+) in aging, metabolism, and neurodegeneration. Science. 2015 Dec 4;350(6265):1208-13. doi: 10.1126/science.aac4854.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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/
Primary Completion
May 16, 2018
Actual (reported)Study Completion
May 24, 2018
Actual (reported)Last Updated
October 18, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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