Healthy Adults
Conditions
Interventions
Ingest 2 tablets of the test food (amino acids containing supplement) each after breakfast and dinner daily for 12 weeks
Ingest 2 tablets of the placebo food (dextrin) each after breakfast and dinner
Sponsors
Healthcare Systems Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persons who provide written informed consent 2. Healthy Japanese who are 20 years old or more and under 64 years old 3. Persons with eGFRcys values in the bottom 40 at screening
Exclusion criteria
Exclusion criteria: 1. Persons who have any chronic illnesses with medication and who have any serious disease histories 2. Persons who are classified in moderate risk or higher (orange or red) of CKD stages 3. Persons who are classified in G3a of GFR categories and under 40 years old 4. Persons who are classified in G1 or G2 of GFR categories, and present with mild proteinuria(0.15~0.49 g/gCr)and hematuria 5. Persons who have a history of CKD diagnosed by markers of kidney damage (albuminuria (AER more thatn 30mg/24 hours; ACR more than 30mg/gCr), urine sediment abnormalities, electrolyte and other abnormalities due to tubular disorders, abnormalities detected by histology, structural abnormalities detected by imaging, or history of kidney transplantation) 6. Persons who have any allergies to the ingredients used in the test food 7. Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect renal function 8. Persons who have participated in other tests within the past one month before the start of test, or those who intend to participate in another exam after consenting to the exam 9. Persons who were judged as inappropriate for study participant by the principal investigator 10. Persons who are breast-feeding, pregnant and planning or wishing to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated glomerular filtration rate cystatin C (eGFRcys) Estimated glomerular filtration rate creatinine (eGFRcrea) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proteinuria Urinary glucose Hematuria Urinary creatinine Urinary albumin Subjective fatigue and sleeping Sleep habit | — |
Countries
Japan
Contacts
Public ContactChihiro Nagayama
Healthcare Systems Co., Ltd. Clinical Research Department
Outcome results
None listed