Healthy participants
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy subjects aged between 18 and 60 years, with a BMI of 20-30 kg/m^2 (inclusive), who self-reported stable weight in the past 6 months (weight loss or gain not exceeding 5 kg within 6 months prior to screening). They should voluntarily participate and commit to complying with the requirements of lifestyle management. From 4 weeks before the intervention to the end of the intervention, they should discontinue the use of any vitamins, minerals, dietary, or other supplements.
Exclusion criteria
Exclusion criteria: 1.Diagnosed diabetes or abnormal glucose metabolism detected during screening (Based on the "Expert Consensus on the Prevention and Treatment of Prediabetes in Chinese Adults (2023 Edition)": Abnormal glucose metabolism is defined as fasting blood glucose >=6.1 mmol/L and glycated hemoglobin >5.7%). 2.Diagnosed dyslipidemia or abnormal lipid metabolism detected during screening (Based on the "Chinese Guidelines for Lipid Management (2023)": Abnormal lipid metabolism is defined as total cholesterol (TC) >5.2 mmol/L, low-density lipoprotein cholesterol (LDL-C) >3.4 mmol/L, triglycerides (TG) >=1.7 mmol/L, and high-density lipoprotein cholesterol (HDL-C) =140/90 mmHg). 4.Abnormal blood routine. 5.Abnormal liver function (alanine aminotransferase, aspartate aminotransferase, direct bilirubin, indirect bilirubin, total bilirubin, alkaline phosphatase (ALP)); Abnormal renal function (serum creatinine, blood urea nitrogen, serum uric acid, urine glucose, urine ketone bodies), or presence of one or more renal injury markers: albuminuria/proteinuria, abnormal urine sediment (e.g., hematuria). 6.Any history of gastrointestinal diseases or other diseases that may affect the study results, or diagnosed with the following diseases: including but not limited to irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, gastrointestinal diseases, endocrine diseases, hematologic diseases, respiratory and cardiovascular diseases, hyperthyroidism or hypothyroidism; severe infections, severe anemia, neutropenia, and other hematologic disorders; presence of psychiatric diseases or dementia. 7.Use of any thyroid medications, lipid-lowering agents, hepatoprotective drugs, antihyperglycemic agents, antihypertensive drugs, antidepressants, or weight-loss medications within the past 3 months. 8.Presence of other infectious diseases, such as hepatitis A, hepatitis B, hepatitis C, and acquired immunodeficiency syndrome. 9.Pregnant or planning to become pregnant within 6 months, or breastfeeding. 10.Participation in another clinical trial within the past 3 months. 11.Refusal to participate or refusal to sign the informed consent form, as well as those deemed ineligible by the investigator. 12.Smoking (more than one pack per week) or habitual alcohol consumption (more than twice per week). 13.Use of probiotics, prebiotics, antioxidants, fish oil, or other nutritional supplements within the past 3 months; consumption of yogurt within 1 week before the initial visit, or use of antibiotics within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GSRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biomarkers;Urinary biomarkers;Gut microbiota;Body composition and measurements;Blood pressure; | — |
Countries
China
Contacts
Nankai University