Safety assesment of NM
- Conditions
- ot applicable
- Registration Number
- JPRN-jRCTs041200034
- Lead Sponsor
- akagawa Takashi
- Brief Summary
Healthy volunteers were treated with NMN or placebo for 12 weeks, and physiological and blood tests were performed to confirm safety. NAD and related metabolites in whole blood were also measured. 12 weeks of oral administration of NMN resulted in no abnormalities in physiological and blood tests and no apparent adverse effects. The concentration of NAD in whole blood increased significantly after NMN administration. A significant increase in NAMN concentration was also observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment<br>(1) Physical measurements<br>height, weight, body fat percentage, BMI, systolic blood pressure, diastolic blood pressure, heart rate<br>(2) Blood test<br>hematology: white blood cell count, red blood cell count, hemoglobin, Hematocrit, platelet count, MCV, MCH, MCHC<br>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<br>(3) Urine testing<br>Sugar, protein, urobilinogen, ketone body, pH, specific gravity, occult blood reaction, bilirubin, sediment (when protein is positive)<br>(4) Diary
- Secondary Outcome Measures
Name Time Method 1. Assessment of the NAD-related metabolites in blood<br>Blood NAD, NMN, nicotinamide, NA, NR, NAR, NAMN, NAAD, MNAM<br>2. Assessment of amino acids in blood<br>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