12-Week Solid Beverage Intervention for Suboptimal Health and Metabolic Risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial enrolls Chinese adults ages 18-60 with BMI ≥25 and mild metabolic abnormalities. Participants are randomly assigned to receive either the active solid beverage or a matching placebo for 12 weeks. The investigational beverage contains postbiotics, Aronia melanocarpa extract, apple polyphenols, D-allulose, inulin, lutein, and other ingredients, while the control beverage is identical in appearance and taste. Primary outcomes focus on glucose and lipid metabolism and changes in body composition, with secondary assessments related to metabolic syndrome indicators. The study plans to enroll around 70 participants, with a minimum valid dataset of 60 analyzed.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai China-norm Quality Technical Service Co., Ltd.
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yanwen Jiang
• Email: jiangyanwen@china-norm.com
• Phone: 13501700841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.