JRCT ID: jRCTs041190080
Registered date:20/11/2019
Safety of Yeast Extract containing NMN
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Not applicable |
Date of first enrollment | 20/11/2019 |
Target sample size | 33 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Oral administration of Yeast extract containing NMN or placebo (Dextran) at 2.8 g/day (14 tablets twice at morning and evening) for 12 weeks.NMN dosages in Yeast extract containing NMN and placebo are 250 mg and 0 mg, respectively. |
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 |
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Secondary Outcome | Assessment the NAD-related metabolites in blood Blood NAD, NMN, nicotinamide, NA, NR, NAR, NAMN, NAAD |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Mitsubishi Corporation Life Sciences Limited |
Secondary ID(s) |
Contact
Public contact | |
Name | Takashi Nakagawa |
Address | 2630 Sugitani, Toyama, Toyama, Japan Toyama Japan 930-0194 |
Telephone | +81-76-434-7262 |
nakagawa@med.u-toyama.ac.jp | |
Affiliation | University of Toyama |
Scientific contact | |
Name | Takashi Nakagawa |
Address | 2630 Sugitani, Toyama, Toyama, Japan Toyama Japan 930-0194 |
Telephone | +81-76-434-7262 |
nakagawa@med.u-toyama.ac.jp | |
Affiliation | University of Toyama |