None listed
Conditions
Interventions
Dietary Supplement : Participants are randomly assigned to either the Nypa fruticans Wurmb. extract group or the placebo group and orally administered the assigned intervention twice daily for 12 week
250 mg/capsule
Nypa fruticans Wurmb. extract 1,000 mg/day)
Placebo group: 2 capsules twice daily, taken orally after meals (1,000 mg/day
Nypa fruticans Wurmb. extract 0 mg/day)
Sponsors
Wonkwang University. Iksan Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals with no history of diabetes treatment within 3 months prior to screening and with fasting blood glucose greater than 70 mg/dL and less than 126 mg/dL at the time of screening 2) Individuals who have received a full explanation of this human application trial, fully understood its contents, voluntarily decided to participate, and provided written informed consent to comply with the study requirements
Exclusion criteria
Exclusion criteria: 1) Individuals requiring diabetes treatment at the time of screening (HbA1c = 6.5%) 2) Individuals with a BMI less than 18.5 kg/m² or 35 kg/m² or greater at the time of screening 3) Individuals with clinically significant acute or chronic cardiovascular/cerebrovascular, endocrine, immune, respiratory, hepatobiliary, renal and urological, neuropsychiatric, musculoskeletal, inflammatory, hematologic/oncologic, or gastrointestinal diseases requiring treatment 4) Individuals who have taken medications or health functional foods related to blood glucose control, such as hypoglycemic agents, anti-obesity drugs, or lipid-lowering agents, within 3 months prior to screening (refer to prohibited concomitant medications) 5) Individuals with abnormal thyroid function (e.g., hyperthyroidism) 6) Individuals with congenital deficiency of glycolytic enzymes 7) Individuals with a history of significant hypersensitivity reactions to components of Nypa fruticans Wurmb. 8) Individuals who have received antipsychotic medication within 3 months prior to screening 9) Individuals with known or suspected alcohol dependence or drug abuse 10) Individuals who have participated in another human application trial within 3 months prior to screening 11) Individuals with the following findings on laboratory tests: ? AST or ALT > 3 times the upper limit of the reference range ? Serum creatinine > 2.0 mg/dL 12) Women who are pregnant or breastfeeding 13) Women of childbearing potential who do not agree to use adequate contraception 14) Individuals deemed ineligible for study participation by the principal investigator based on laboratory test results or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose and postprandial blood glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting insulin and postprandial insulin;AUC : area under the concentration-time curve (glucose, insulin);Cmax: Maximum concentration , Tmax :ime to maximum concentration (glucose, insulin);Insulin-related indices: HOMA-IR (Homeostatic Model Assessment of Insulin Resistance), HOMA-ß (Homeostatic Model Assessment of Beta-cell function);Blood glucose-related index: Glycated hemoglobin (HbA1c);Blood glucose-related indices: C-peptide, Adiponectin, Leptin;Lipid metabolism indices: Total cholesterol, HDL cholesterol, LDL cholesterol, Triglyceride | — |
Countries
Korea, Republic of
Contacts
Public ContactWonbae Ha
Wonkwang University. Iksan Korean Medicine Hospital
Outcome results
None listed