Recruiting
Not applicable
Effects of a 12-Week Solid Beverage Intervention on Suboptimal Health Status
Condition(s) studied
Metabolic DisorderSub-health Status
Investigational drug(s) / intervention(s)
Meta Solid Beverage AMeta Solid Beverage B
Meta Solid Beverage A: Solid beverage containing postbiotics BPL1, \*Aronia melanocarpa\* fruit extract, apple polyphenols, D-allulose, inulin, lutein and other ingredients. Subjects consume \*\*1 sachet per day\*\* during the study period; each sachet is reconstituted with 150 mL warm water, fully mixed and then ingested.
Meta Solid Beverage B: Placebo solid beverage with identical appearance, taste and packaging to the investigational product. It does not contain postbiotics BPL1, \*Aronia melanocarpa\* fruit extract, apple polyphenols, D-allulose, inulin, lutein or other active ingredients. Subjects consume this placebo daily during the study period.
Study summary
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 the investigational product in appearance, taste and packaging but without the above active ingredients.
Eligibility
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.
Primary outcome measure(s)
- Change in Metabolic Syndrome Risk Index (MetS) — Baseline and 12 weeks after intervention
Change from baseline in Metabolic Syndrome Risk Index (MetS). This composite index integrates body composition, glucose metabolism and lipid metabolism indicators to assess the overall metabolic risk and systemic sub-health improvement of subjects.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Shanghai China-norm Quality Technical Service Co., Ltd. |
Shanghai |
Shanghai Municipality |
Recruiting |
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