NMN Human Safety Trial Concludes in Japan

1.   Hi and welcome back, if you are new to the podcast, thanks for tuning in, you are very welcome here indeed.

 So, a non-blinded clinical trial has been conducted at the Clinical Trial Unit, Keio University’s School of Medicine in Japan, the study was on 10 healthy men aged between 40 and 60, the aim was to ensure that there were no adverse side effects to taking NMN.

 2.   A non-blinded trial describes a clinical trial, or other experiment, in which the researchers know what treatments are being given to each study subject, and the subjects involved know what treatments they are receiving.

 This small human trial of NMN achieved what it set out to establish: to demonstrate that the supplement is safe and well tolerated, at the dosage used, on humans.

 The trial did not set out to demonstrate the efficacy of NMN, and given the small number of trial participants, the single dose, and the short study time, it was never going to do more than establish that the drug is safe for human use.

 3.   Some volunteers were excluded from the trail, if they fell into the following categories:

·      Previous history of diseases, but nothing specific described in the report

·      Malignant neoplasms, which means a tumor that is cancerous

·      Serious infections, not specified, but maybe infections such as Influenza, an STD, hepatitis, HIV or MRSA

·      Psychiatric disorders, again not specified, but maybe Bipolar disorder, anxiety disorders, PTSD or Schizophrenia

·      Ophthalmic disorders, again not specified, but maybe Conjunctivitis, Cataracts, Glaucoma

·      Allergic disorders, maybe asthma, food allergies, medication allergies

·      Metabolic diseases

 4.   During the study (for 5 hours after the administration) the researchers observed various biomarkers such as:

·      Heart rate

·      Blood pressure

·      Oxygen saturation

·      Body temperature

Urine was collected every 30 to 60 minutes for the first 2 hours after administration and at the end of the study. Blood was collected every 5 to 20 minutes for the first hour, followed by every 30 to 120 minutes for the next 4 hours.

5.   Ophthalmic examinations (on the left eyes) were conducted (by registered op-thalmologists) on the day of intervention, both before and after the administration, covering visual acuity and functional visual acuity; this includes:

·      The sharpness of the retinal focus within the eye,

·      The health and functioning of the retina

·      The sensitivity of the interpretive faculty of the brain

The quality of sleep was also evaluated, it was evaluated using the Pittsburgh Sleep Quality Index (PSQI) before and after the day of intervention.

6.   The researchers could not detect NMN in the blood samples taken during the study, but this is likely due to them being frozen, which may have degraded the NMN.

So, could freezing NMN also cause some degradation, or was it because the blood plasma acted as catalyst? Interesting, as keeping NMN refrigerated or frozen is now the norm in the NMN community. The report also mentions that NMN degrades rapidly in blood that was handled above 80 degrees centigrade (176 F).

 7.   So, onto the results

Results of ophthalmic examination and sleep quality score showed no differences before and after the intervention.

The only notable result was that bilirubin levels rose by 51.3% and glucose fell by 11.7. However, it was concluded that those two changes were most likely associated with the overnight fast prior to taking NMN and the five-hour fast following administration.

 8.   No significant changes were evident following the single dose of NMN, although this was to be expected, as the dosage range used of 100, 250, and 500 mg was fairly low.

 The single oral administration of NMN was safe and effectively metabolized in healthy men without causing any significant harmful effects.

 So, oral administration of NMN was found to be feasible. These results are fairly unimpressive, but this is a good thing, it means the study was a success, in that NMN is safe for humans to take, well at least in the short term and in the doses used during the clinical trial.

Notable limitations worthy of mention are that this was not a placebo-controlled study and that NAD+ and plasma NMN levels were not measured in this study

9.   In summary, there have been a lot of animal studies; however, the safety and efficacy of NMN in humans was unclear, this trial helps to confirm that, in general, the compound is safe and well tolerated; to that end, the trial can be considered a success.

The next step for researchers will be to investigate the efficacy of NMN; then hopefully a suitable dosage and frequency protocols can be officially established.

 10. Of course, it is certainly possible that NMN may fail during efficacy testing in humans, but this initial safety study has no bearing on that potential outcome.

There is currently an ongoing human trial for NMN at the Brigham and Women’s Hospital in Boston, from which efficacy data should be forthcoming, until that data is posted, no real conclusions, beyond NMN being safe for human consumption, can really be drawn.

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