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Japanese NMN Trials

nicotinamide mononucleotide

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#1 Michael

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Posted 10 April 2018 - 04:30 PM


All:
 
Many of us will have seen the npj Aging and Mechanisms of Disease news story "The first human clinical study for NMN has started in Japan" that accompanied the Elysium Basis trial. It linked the entry in the Japanese clinical trial registry. Here are the English-language registry entries for current and upcoming NMN trials there:
 

Official scientific title of the study Assessment of the safety of nicotinamide mononucleotide (NMN) in healthy subjects; phase I study. The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims.
Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021309
Date of disclosure of the study information 2016/03/03
Last modified on 2016/08/04

Blinding Open -no one is blinded
Control Uncontrolled
Age-lower limit 40 years-old <=
Age-upper limit 60 years-old >=
Gender Male
Key inclusion criteria the healthy subjects who agree to the study.

Name of lead principal investigator Hiroshi Itoh
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology
Recruitment status No longer recruiting
Publication of results Unpublished
Funding Source
Organization Keio University


 

Official scientific title of the study Assessment of the safety of long-term nicotinamide mononucleotide (NMN) in healthy subjects; phase II study. The clinical trial to evaluate metabolic-syndrome-related parameters to develop NMN as Foods with Function Claims.
Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030609
Date of disclosure of the study information 2017/12/29
Last modified on 2018/01/05
Primary outcomes the safety of long-term (8weeks) NMN (physical and laboratory examinations).
Key secondary outcomes the kinetics of NMN and metabolites of nicotinamide.
Study type Interventional

Study design
Basic design
Single arm
Randomization Non-randomized

Blinding Open -no one is blinded
Control Uncontrolled
Age-lower limit 40 years-old <=
Age-upper limit 60 years-old >=
Gender Male
Key inclusion criteria the healthy subjects who agree to the study.

Name of lead principal investigator Hiroshi Itoh
Organization Keio University School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology

Funding Source
Organization
ORIENTAL YEAST CO.,LTD

 
 

Official scientific title of the study Effect of long-term oral administration of nicotinamide mononucleotide (NMN) on human health
Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025739
Date of disclosure of the study information 2017/01/20
Last modified on 2017/07/21

Assessment
Primary outcomes

i) Serum or plasma concentration of the following parameters at baseline, weeks 4, 8, 12, 18, and 24.

*Thyroid-stimulating hormone (TSH)
*Free triiodothyronine (Free T3)
*Free thyroxine (Free T4)
*Growth hormone (GH)
*Prolactin
*Parathyroid hormone (PTH)
*Dehydroepiandrosterone sulfate (DHEA-S)
*Estradiol (E2)
*Testosterone
*Calcitonin
*Adrenocorticotropic hormone (ACTH)
*Arginine vasopressin (AVP)
*Cortisol
*Aldosterone
*Ghrelin
*Inhibin
*Melatonin

ii) Mitochondria activity in leucocyte at baseline and week 24.
iii) Sirt1 and Sirt2 gene expressions in leucocyte at baseline and week 24.
Key secondary outcomes Number and rate of adverse events.

Study type Interventional

Study design
Basic design
Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Interventions/Control_1 Subjects receive 100 mg/day of NMN for 24 weeks.
Interventions/Control_2 Subjects receive 200 mg/day of NMN for 24 weeks.

Age-lower limit 50 years-old <=
Age-upper limit 70 years-old >=
Gender Male and Female
Key inclusion criteria Healthy

Name of lead principal investigator Fumiko Higashikawa
Organization Hiroshima University, Institute of Biomedical & Health Sciences
Division name Project Research Center for Clinical Trial and Preventive Medicine

Funding Source
Organization
Hakushindo Pharmaceutical Co.,Ltd


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#2 malbecman

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Posted 12 April 2018 - 09:34 PM

 Here is an editorial about it in Nature

 

https://www.nature.c...es/npjamd201621


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#3 Nate-2004

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Posted 13 April 2018 - 03:38 PM

 Here is an editorial about it in Nature

 

https://www.nature.c...es/npjamd201621

 

Funny how the guy claims the changes in lifestyle required are "moderate". Calorie restriction may only have a modest effect on aging in humans, but the changes required in lifestyle to meet CR requirements are fairly significant and difficult for the vast majority of people.  Trying to limit my calories to 1000 a day would end up being pretty miserable. Life would only seem longer, because that's how torture works. All I would ever think about is food.

 

I'll fast 24 hrs a week, but I'm hoping NMN or better options hit the market soon.


Edited by Nate-2004, 13 April 2018 - 03:40 PM.


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#4 Mind

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Posted 13 April 2018 - 05:09 PM

I have started short-term fasting because there is nothing better out there to combat aging (exercise a lot as well).

 

When anti-aging therapeutics/therapies arrive, I will taper off on the fasting....because I want to enjoy life and enjoy food.

 

Thanks for keeping us up-to-date on the NMN trials Michael.


Edited by Mind, 13 April 2018 - 05:10 PM.

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#5 Joe Garma

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Posted 06 February 2019 - 06:42 PM

Funny how the guy claims the changes in lifestyle required are "moderate". Calorie restriction may only have a modest effect on aging in humans, but the changes required in lifestyle to meet CR requirements are fairly significant and difficult for the vast majority of people.  Trying to limit my calories to 1000 a day would end up being pretty miserable. Life would only seem longer, because that's how torture works. All I would ever think about is food.

 

I'll fast 24 hrs a week, but I'm hoping NMN or better options hit the market soon.

 

Nate, the two currently most researched NAD+ precursors, NMN and NR, are both available to the public. Elysium Health sells a NR supplement called Basis. NMN is what NMN researcher Dr. David Sinclair takes himself, and a few companies offer that. I compared both precursors here:

https://www.garmaonh...mn-young-again/


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#6 Born2Forlife

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Posted 11 February 2019 - 06:24 PM

Nate, the two currently most researched NAD+ precursors, NMN and NR, are both available to the public. Elysium Health sells a NR supplement called Basis. NMN is what NMN researcher Dr. David Sinclair takes himself, and a few companies offer that. I compared both precursors here:

https://www.garmaonh...mn-young-again/

 

Does anyone know where Dr. Sinclair gets the NMN that he consumes?  Also, how sure are we that NMN won't cause any adverse side-effects?  Sorry if this is a newbie question, I've been reading about it, but still learning.



#7 Joe Garma

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Posted 11 February 2019 - 11:56 PM

Does anyone know where Dr. Sinclair gets the NMN that he consumes?  Also, how sure are we that NMN won't cause any adverse side-effects?  Sorry if this is a newbie question, I've been reading about it, but still learning.

 

Don't know where Dr. Sinclair gets his NMN, but probably from some manufacturing source unavailable to us.  I've taken both NR for about two years and NMN for three months and have had no adverse side-effects, nor has anyone I know who takes them. Sinclair and his family consume one gram per day of NMN and have had no problems, just the opposite.


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#8 LawrenceW

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Posted 12 February 2019 - 12:46 AM

Does anyone know where Dr. Sinclair gets the NMN that he consumes?  Also, how sure are we that NMN won't cause any adverse side-effects?  Sorry if this is a newbie question, I've been reading about it, but still learning.

 

 

I've been taking NMN since July 2015 and the only side effect that I have noticed is a rapid slimming of the wallet!


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#9 Phoebus

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Posted 12 February 2019 - 07:17 PM

Does anyone know where Dr. Sinclair gets the NMN that he consumes?  Also, how sure are we that NMN won't cause any adverse side-effects?  Sorry if this is a newbie question, I've been reading about it, but still learning.

 

 

read about personal experiences here, adverse side effects are few and far between 

 

https://www.longecit...erience-thread/

 

Sinclair likely gets his direct from some super lab somewhere, its almost certainly not from a commercial source that you and I can access. 


Edited by Phoebus, 12 February 2019 - 07:49 PM.


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