Target condition (Condition) Healthy subjects and pre-symptomatic subjects (pre-metabolic syndrome, subjects with high blood glucose levels) Classification by specialty Internal Medicine (Metabolism / Endocrinology)
Conditions
Interventions
Consumption of the test food "
Tenku Kuwa Aojiru"
(3g/pack) once daily for 4 weeks.
Sponsors
Other
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males and females in their 20s to 70s Subjects who understand the purpose and content of this study and provide written informed consent (Blood glucose group only) Subjects capable of participating in blood sampling at the designated location (Body weight group only) Subjects capable of measuring and recording body weight and body fat percentage at home
Exclusion criteria
Exclusion criteria: Subjects with a history of serious diseases such as kidney disease Subjects taking medications or supplements unsuitable for the study Subjects who are pregnant, lactating, or possibly pregnant Subjects with an allergy to mulberry leaves Subjects currently receiving treatment for diabetes (insulin injections or oral hypoglycemic agents) Other subjects deemed inappropriate by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in postprandial blood glucose levels (comparison between pre-intake and 4 weeks post-intake) Changes in body weight, body fat percentage, and BMI (comparison between pre-intake and 4 weeks post-intake) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in blood biochemical parameters (HbA1c, Triglyceride, Total cholesterol, HDL cholesterol, Uric acid, Total protein, Albumin, AST, ALT, gamma-GT, BUN, Creatinine) Changes in subjective physical conditions via questionnaire (stomach condition, skin condition, quality of awakening, other subjective symptoms) Evaluation of product palatability and acceptability (ease of drinking, taste, intention to continue drinking) Presence and details of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroki Fuchigami
Atsumaru Holdings Co., Ltd. NSP Yamaga Factory Production Management Department
Outcome results
None listed