Safety of Yeast Extract containing NM

Phase 1

• Conditions: ot applicable

• Registration Number: JPRN-jRCTs041190080
• Lead Sponsor: akagawa Takashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 33

Inclusion 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

Exclusion 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.

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
Assessment the NAD-related metabolites in blood<br>Blood NAD, NMN, nicotinamide, NA, NR, NAR, NAMN, NAAD