NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041190080

Registered date:20/11/2019

Safety of Yeast Extract containing NMN

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedNot applicable
Date of first enrollment20/11/2019
Target sample size33
Countries of recruitment
Study typeInterventional
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 OutcomeSafety 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 OutcomeAssessment the NAD-related metabolites in blood Blood NAD, NMN, nicotinamide, NA, NR, NAR, NAMN, NAAD

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 65age old
GenderBoth
Include criteria1. 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 criteria1.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

Contact

Public contact
Name Takashi Nakagawa
Address 2630 Sugitani, Toyama, Toyama, Japan Toyama Japan 930-0194
Telephone +81-76-434-7262
E-mail 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
E-mail nakagawa@med.u-toyama.ac.jp
Affiliation University of Toyama