None listed
Conditions
Interventions
Dietary Supplement : Group A : Single ingestion of Nypa fruticans sprout extract ? 1-week washout period ? Single ingestion of Placebo
Group BSingle ingestion of Placebo ? 1-week washout period ? Sing
Sponsors
Wonkwang University. Iksan Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals with no history of treatment for diabetes mellitus within 3 months prior to the screening examination, and whose fasting blood glucose level at the time of screening is greater than 70 mg/dL and less than 126 mg/dL. 2) Individuals who have fully understood the detailed explanation of this human application test (clinical trial), voluntarily decided to participate, and provided written informed consent to comply with the precautions.
Exclusion criteria
Exclusion criteria: 1) Individuals who require treatment for diabetes (e.g., those with a HbA1c level of 6.5% or higher) at the time of the screening examination. 2) Individuals whose BMI is less than 18.5kg/? or 35kg/? or higher at the time of the screening examination. 3) Individuals with clinically significant acute or chronic diseases requiring treatment, including those of the cardiovascular, cerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory, and hematologic/oncologic systems. 4) Individuals who have taken medicines or health functional foods related to blood glucose, such as antidiabetic drugs, anti-obesity drugs, or lipid-lowering agents, within 3 months prior to the screening examination. 5) Individuals with abnormal thyroid function (e.g., hyperthyroidism, etc.). 6) Individuals with a congenital deficiency of sugar-degrading enzymes (e.g., sucrase-isomaltase deficiency, lactase deficiency, etc.). 7) Individuals with a history of significant hypersensitivity reactions to Nypa fruticans sprout extract ingredients. 8) Individuals who have received antipsychotic drug treatment within 3 months prior to the screening examination. 9) Individuals who have or are suspected of having alcoholism or substance abuse. 10) Individuals who have participated in other human application tests (clinical trials) within 4 months prior to the screening examination. 11) Individuals showing the following results in Laboratory Medicine Tests (e.g., AST or ALT > 3 times the upper limit of the reference range, or Serum Creatinine > 2.0 mg/dL). 12) Women who are pregnant or breastfeeding. 13) Women of childbearing potential who do not agree to use an appropriate method of contraception. 14) Individuals whom the Principal Investigator deems inappropriate for participation in the study due to other reasons, including the results of laboratory tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial Blood Glucose(30min, 60min, 90min, 120min) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Suga;AUC: area under the curve(Glucose) | — |
Countries
Korea, Republic of
Contacts
Public ContactWonbae Ha
Wonkwang University. Iksan Korean Medicine Hospital
Outcome results
None listed