Healthy volunteers
Conditions
Interventions
Intake of test food for 4 weeks (once a day, 6 capsules)
Sponsors
Megmilk Snow Brand Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 20-64 years 2) Those who received a sufficient explanation of the study's objectives and procedures, fully understood the information, voluntarily agreed to participate, and were able to personally sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1) Persons with a medical history of or receiving medical treatment for the following diseases: diabetes, or renal, hepatic, cardiovascular, thyroid, adrenal, or metabolic diseases 2) Persons regularly taking medicines for chronic diseases 3) Persons regularly consuming foods containing lactic acid bacteria, bifidobacterium, oligosaccharide, live microbes, or fermented food 4) Persons taking supplements, consuming a diet, or taking medicines that affect fatigue or sleep 5) Persons working day-night shifts, irregular shifts, or those working night shifts twice during the study period 6) Persons with irregular holidays 7) Persons engaging in manual labor such as heavy cargo transport 8) Persons smoking 21 or more cigarettes a day 9) Persons regularly consuming high-caffeine drinks (equivalent to seven or more cups of coffee a day) 10) Persons with allergic symptoms to certain foods 11) Persons with substance dependence, alcohol use disorder, or those with a medical history of these disorders 12) Persons who are pregnant or lactating, or intending to become pregnant during the study period 13) Persons who have donated more than 200 ml of blood within 1 month, more than 400 ml within 3 months, or plasma or platelet within 2 weeks prior to providing informed consent section for this study 14) Persons who took part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in or intending to take part in another clinical study during the study period 15) Persons deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood D-serine and D-alanine concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood L-serine and L-alanine concentration, D/L-serine ratio, and D/L-alanine ratio Urine L-serine and L-alanine concentration, D/L-serine ratio, D/L-alanine ratio, D-serine/creatinine ratio, and D-alanine/creatinine ratio Fecal L-serine and L-alanine concentration, D/L-serine ratio, and D/L-alanine ratio Intestinal bacterial count by real-time PCR | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed