Safety assesment of NMN

JRCT ID: jRCTs041200034

Registered date:20/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 19/02/2021
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Oral administration of NMN 6 tablets/day (as NMN 250mg/day) or placebo (No NMN is contained) 6 tablets/dayfor 12 weeks.

Outcome(s)

Primary Outcome

Safety assessment
(1) Physical measurements
height, weight, body fat percentage, BMI, systolic blood pressure, diastolic blood pressure, heart rate
(2) Blood test
hematology: white blood cell count, red blood cell count, hemoglobin, Hematocrit, platelet count, MCV, MCH, MCHC
b. Biochemical tests: TG, total cholesterol, LDL-cholesterol, HDL-cholesterol, free fatty acid, acetoacetic acid, 3-hydroxyacetic acid, total ketone body, lipoprotein (a), glucose, HbA1c, insulin, AST , ALT, gamma-GTP, ALP, LDH, total protein, albumin, uric acid, urea nitrogen, creatinine, sodium, chloride, potassium, calcium, inorganic phosphorus, magnesium
(3) Urine testing
Sugar, protein, urobilinogen, ketone body, pH, specific gravity, occult blood reaction, bilirubin, sediment (when protein is positive)
(4) Diary

Secondary Outcome

1. Assessment of the NAD-related metabolites in blood
Blood NAD, NMN, nicotinamide, NA, NR, NAR, NAMN, NAAD, MNAM
2. Assessment of amino acids in blood
Blood tryptophan, asparagine, aspartic acid, glutamine, glutamic acid, leucine, isoleucine, lysine, methionine, phenylalanine, threonine, valine, histidine, tyrosine, cysteine, aspartic acid, asparagine, serine, glutamic acid, glutamine, proline, Glycine, alanine, arginine

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1. Healthy Japanese volunteer with age between 20 and 65
2. Qualified person judged by medical doctor based on the results of clinical laboratory test:
TG, LDL-cholesterol, fasting glucose, HbA1c, AST, ALT, gamma-GTP, Serum amylase, Creatinine

Exclude criteria

1.Person with past treatment history of malignant tumor, heart failure, or myocardial infarction.
2.Person currently under treatment for atrial fibrillation, arrhythmia, hepatic dysfunction, renal dysfunction, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases.
3.Person with medication (including Kampo medicine).
4.Person with allergy against medicine or the test food
5.Pregnant, unwilling to practice contraception during the study, or lactating female
6.Person who is not judged as not qualified by the medical doctor.

Related Information

• Primary Sponsor: Nakagawa Takashi
• Source(s) of Monetary Support: Mitsubishi Corporation Life Sciences Limited