💬In plain words
What the trial is, and whether it could suit you
This is a randomized, double-blind, placebo-controlled clinical trial targeting Chinese overweight/obese subjects aged 18-60 years with mild metabolic abnormalities. A total of 70 study participants are planned to be enrolled (the sample size requirement will be satisfied if the final valid dataset includes no fewer than 60 participants). The study aims to explore the effects of 12-week product intervention on glucose and lipid metabolism, body composition, and indicators related to metabolic syndrome.
This study adopts a double-blind design. All study participants will be randomly assigned into two groups. One group will receive the investigational product, a solid beverage containing postbiotics BPL1, \*Aronia melanocarpa\* fruit extract, apple polyphenols, D-allulose, inulin, lutein and other ingredients. The other group will receive the placebo control, a solid beverage identical to
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age: 18-60 years, no gender restriction;
2. BMI ≥ 25.0 kg/m² (mandatory criterion);
3. Mild abnormalities in biochemical indicators: Fasting blood samples shall be collected during the screening period for testing of the following indicators. Subjects shall meet at least one criterion for mild abnormality, and none of the indicators shall reach the diagnostic threshold (see Item 2 of Exclusion Criteria for diagnostic thresholds):
* Fasting blood glucose: 6.1 - 6.9 mmol/L (Expert Consensus on the Intervention of Prediabetes in Chinese Adults (2023 Edition))
* Triglyceride: 1.7 - 2.2 mmol/L (Chinese Guidelines for Lipid Management (2023 Edition))
* Total cholesterol: 5.2 - 6.1 mmol/L (Chinese Guidelines for Lipid Management (2023 Edition))
* Low-density lipoprotein cholesterol: 3.4 - 4.0 mmol/L (Chinese Guidelines for Lipid Management (2023 Edition))
* Apolipoprotein B: 110 - 129 mg/dL (Chinese Guidelines for Lipid Management (2023 Edition))
4. Voluntary participation: Signed informed consent form and willingness to comply with study procedures.
Exclusion Criteria:
1. Confirmed diagnosed diseases: diabetes mellitus, hypertension, drug-treated hyperlipidemia, coronary heart disease, cerebrovascular diseases, etc.
2. Biochemical indicators reaching diagnostic thresholds (corresponding to the above inclusion indicators; subjects will be excluded if any single indicator meets the threshold):
* Fasting blood glucose ≥ 7.0 mmol/L (Expert Consensus on the Intervention of Prediabetes in Chinese Adults (2023 Edition))
* Triglyceride ≥ 2.3 mmol/L (Chinese Guidelines for Lipid Management (2023 Edition))
* Total cholesterol ≥ 6.2 mmol/L (Chinese Guidelines for Lipid Management (2023 Edition))
* Low-density lipoprotein cholesterol ≥ 4.1 mmol/L (Chinese Guidelines for Lipid Management (2023 Edition))
* Apolipoprotein B ≥ 130 mg/dL (Chinese Guidelines for Lipid Management (2023 Edition))
3. Concurrent use of metabolism-affecting medications: hypoglycemic agents, lipid-lowering drugs (statins, fibrates), weight-loss drugs, glucocorticoids, etc.
4. Use of antibiotics within the past 3 months; or consumption of functional foods, beverages and nutritional supplements of similar categories including probiotics, prebiotics, high dietary fiber, polyphenols, lutein, D-allulose, postbiotics (such as prune enzymes, high-fiber meal replacement drinks, solid/liquid beverages for metabolic regulation, etc.), or other products judged by the investigator to potentially interfere with study evaluation.
5. Pregnant or lactating women.
6. History of severe gastrointestinal diseases or gastrointestinal surgery.
7. Known allergy to any ingredient of the investigational product.
8. Subjects with other iatrogenic factors deemed by experts or investigators to affect the evaluation results.
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