None listed
Conditions
Interventions
Dietary Supplement : Protocol ?
Nucare Sugar Care or Nucare Savory Flavor
1 pack (200kcal), once a day, single administration
Protocol ?
Nucare Sugar Care Pro or Nucare Savory Flavor
1 pack (140kcal)
Sponsors
Daesang Wellife
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult aged 19 to 65 2. Individuals diagnosed with prediabetes or defined as follows: I. HbA1c: equal to or greater than 5.7% and less than 6.5%, or II. Fasting plasma glucose: equal to or greater than 100mg/dL and less than 126mg/dL 3. A person who voluntarily agrees to participate in the study and signs an informed consent form
Exclusion criteria
Exclusion criteria: 1. A person who is diagnosed with type 1 diabetes 2. A person who is diagnosed with type 2 diabetes or defined as follows: I. HbA1c: equal to or greater than 6.5% and II. Fasting plasma glucose: equal to or greater than 126mg/dL 3. A person with fasting plasma glucose equal to or greater than 180mg/dL 4. A person with HbA1c levels equal to or greater than 8.0% 5. A person taking oral antidiabetic agents except metformin or undergoing insulin treatment 6. A person continuously taken medications or health functional foods that affect blood glucose changes for at least one month prior to enrollment - antidepressants, corticosteroids, antiepileptics, contraceptives, and other drugs affecting blood glucose/appetite/energy metabolism 7. A person with a BMI equal to or less than 18.5 kg/m^2 or equal to or greater than 30.0 kg/m^2 8. A person with uncontrolled hypertension patients (systolic blood pressure equal to or above 160mmHg or diastolic blood pressure equal to or above 100mmHg) 9. A person with AST, ALT, or Cr levels more than twice the normal range 10. A person with gastrointestinal disorders that could affect the absorption of the test product or a history of gastrointestinal surgery (excluding simple appendectomy or hernia surgery) 11. A person with or with a history of cardiovascular, endocrine metabolic, respiratory, hepatobiliary, renal, blood, or tumor disorders requiring treatment 12. A person with chronic infections such as tuberculosis, hepatitis B, hepatitis C, HIV, etc 13. A person with abnormal thyroid function 14. A person practicing specific dietary regimens 15. A person allergic or hypersensitive to the components of the test product 16. A person with a history of alcohol addiction or suspected alcohol abuse 17. A person who participated in another clinical trial one month before participation in the test 18. A person who pregnant or lactating 19. A person who is illiterate or whose ability is limited 20. A person deemed inappropriate by the principal investigator to participate in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response area under the curve of the glucose concentration (0-180min) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time point concentrations of glucose (0, 30, 60, 90, 120, 180 minutes);Time point concentrations of insulin (0, 30, 60, 90, 120, 180 minutes) and response area under the curve of the insulin concentration (0-180min);Time point concentrations of c-peptide (0, 30, 60, 90, 120, 180 minutes) and response area under the curve of the c-peptide concentration (0-180min) | — |
Countries
Korea, Republic of
Contacts
Public ContactMiji Lee
Research Institute of Medical Nutrition
Outcome results
None listed