None listed
Conditions
Interventions
Dietary Supplement : For a total of 8 weeks, subjects consumed 1 sachet/day of the test product (WDLS9) or the control product, mixed with 350 mL of water, as breakfast (after mixing, let it soak for
then drink an additional 200 mL of lukewarm water).
Test Product:
Formulation: Powder
Weight: 49 g/sachet
Calories: 237 kcal/sachet (E% of carbohydrate, fat, protein: 23.2, 54.3, 32.7, respectively)
then drink an additional 200 mL of lukewarm water)
Control Product:
Formulation: Powder
Weight: 51 g/sachet
Calories: 237 kcal/sachet (E% of carbohydrate, fat, protein: 60.0, 24.7, 15.3, respectively
then drink an additional 200 mL of lukewarm water)
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those who have consented to participate in this study and signed the written informed consent form 2) Adult men and women aged 19 to 75 years 3) Those with a fasting blood glucose of 100 to under 140 mg/dL, or HbA1c of 5.7% to under 7.0% (if the fasting blood glucose result falls outside the criteria, retesting may be performed considering test error and daily variation) 4) Those with a body mass index of 23.0 to under 30.0 kg/m²
Exclusion criteria
Exclusion criteria: 1) Those who have taken, within 1 month before the first visit, or may take during the study period, medications affecting body weight, blood glucose, lipids, or gut health: appetite suppressants/stimulants, diuretics, beta-blockers, contraceptives, hormone agents (estrogen, androgen, thyroid hormone, steroid agents, etc.), TCAs, laxatives, hypoglycemic agents, lipid-lowering agents, antidepressants, inflammatory bowel disease treatments, etc. (However, subjects taking diuretics or thyroid hormone agents at a stable dose since at least 3 months before the first visit, with no anticipated dose change during study participation, may be included.) 2) Those with any of the following conditions: ? Uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg) ? Those receiving antidiabetic agents (oral hypoglycemic agents, insulin, etc.) for diabetes ? Those with a fasting blood glucose = 140 mg/dL or HbA1c = 7.0% ? Hepatic dysfunction (AST or ALT = 3 times the upper limit of normal) or hepatobiliary disease requiring treatment ? Renal dysfunction (serum creatinine = 2 times the upper limit of normal, or eGFR 10 µU/mL), Cushing's syndrome ? Those who have or had a history of severe central nervous system disorders requiring hospitalization or drug treatment (depression, schizophrenia, epilepsy, alcoholism, drug addiction, eating disorders, etc.) ? Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) or heart disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment, etc.) ? Those with malignant tumors, pulmonary disease, musculoskeletal disease, immune or inflammatory disease, or gastrointestinal disease requiring treatment; those complaining of severe gastrointestinal symptoms such as heartburn, dyspepsia, or severe constipation; or those with a history of gastrointestinal surgery 3) Those who have undergone surgery such as gastroplasty or intestinal resection for weight loss 4) Those who have participated in a commercial obesity program or followed a calorie-restricted diet (intermittent fasting, single-food diet, etc.) within 3 months before the first visit 5) Those currently losing weight or who have had a body weight change of 10% or more within 3 months before the first visit 6) Those with good dietary quality (Recommended food score > 36 points) 7) Those who regularly perform high-intensity exercise continuously (> 10 hours/week) 8) Excessive smokers (= 20 cigarettes/day) 9) Those who have continuously consumed health functional foods or herbal medicines within 1 month before the first visit 10) Those who have continuously consumed foods that may affect gut health within 1 month before the first visit: probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharides, etc.) 11) Those who have participated in another clinical trial within 1 month before the first visit, or who plan to participate in another clinical trial during this human application study period 12) Pregnant or lactating women, or those who plan to become pregnant during this human application study period 13) Those with hypersensitivity to ingredients contained in the test/control products, or with a history of severe food allergic reactions 14) Those deemed by the investigator to be inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood glucose levels and related biomarkers | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut Quotient;Safety assessments: Adverse events, vital signs, and clinical laboratory tests | — |
Countries
Korea, Republic of
Contacts
Public ContactChae Min Moon
Yonsei University Health System, Severance Hospital
Outcome results
None listed