Metabolic DisorderNCT07884643
Effects of a 12-Week Solid Beverage Intervention on Suboptimal Health Status
A study testing Meta Solid Beverage A and Meta Solid Beverage B in people with Metabolic Disorder and Sub-health Status, run by ChinaNorm at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorder, Sub-health Status
- What is being tested?
- Meta Solid Beverage A and Meta Solid Beverage B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2026to 17 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-60 years, no gender restriction;
- BMI ≥ 25.0 kg/m² (mandatory criterion);
- 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))
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- 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))
- Voluntary participation: Signed informed consent form and willingness to comply with study procedures.
Who cannot join
- Confirmed diagnosed diseases: diabetes mellitus, hypertension, drug-treated hyperlipidemia, coronary heart disease, cerebrovascular diseases, etc.
- 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))
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- Apolipoprotein B ≥ 130 mg/dL (Chinese Guidelines for Lipid Management (2023 Edition))
- Concurrent use of metabolism-affecting medications: hypoglycemic agents, lipid-lowering drugs (statins, fibrates), weight-loss drugs, glucocorticoids, etc.
- 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.
- Pregnant or lactating women.
- History of severe gastrointestinal diseases or gastrointestinal surgery.
- Known allergy to any ingredient of the investigational product.
- Subjects with other iatrogenic factors deemed by experts or investigators to affect the evaluation results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072
Yanwen Jiang, +86 13501700841, jiangyanwen@china-norm.com
About this study
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.
- Conditions
- Metabolic Disorder, Sub-health Status
- Being tested
- Meta Solid Beverage A, Meta Solid Beverage B
- Keywords
- Metabolic Disorders, Sub-health Status
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta Solid Beverage AOther
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 BOther
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 group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Subjects consume the investigational solid beverage containing postbiotics BPL1, *Aronia melanocarpa* fruit extract, apple polyphenols, D-allulose, inulin, lutein and other ingredients. Receives: Other: Meta Solid Beverage A |
| Placebo Control Arm | Placebo comparator | Subjects consume placebo solid beverage. The placebo has identical appearance, taste and packaging to the investigational product, but does not contain the above active ingredients. Receives: Other: Meta Solid Beverage B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Metabolic Syndrome Risk Index (MetS)
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.
Measured: Baseline and 12 weeks after intervention
Secondary outcomes (22)
Change in waist circumference
Change from baseline in waist circumference, to assess central obesity improvement.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in basal metabolic rate calculated by Cunningham formula
Change from baseline in basal metabolic rate calculated by Cunningham formula, derived from body fat percentage, to assess changes in resting energy consumption.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in fasting blood glucose
Change from baseline in fasting blood glucose, to evaluate glucose metabolism status.
Measured: Baseline and 12 weeks after intervention
Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)
Change from baseline in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance). HOMA-IR is a single derived value calculated using fasting blood glucose and fasting insulin, to assess insulin sensitivity.
Measured: Baseline and 12 weeks after intervention
Change in systolic blood pressure and diastolic blood pressure
Change from baseline in systolic blood pressure and diastolic blood pressure, to evaluate vascular function, which is not included in Metabolic Syndrome Risk Index aggregation.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in palm skin surface temperature
Change from baseline in palm skin surface temperature, for objective evaluation of peripheral microcirculation improvement, associated with relief of cold extremity symptoms.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in SF-36 health survey summary score
Change from baseline in the 36-Item Short Form Health Survey (SF-36). SF-36 yields two summary scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Each summary score ranges from 0 to 100, higher scores indicate better health-related quality of life, to assess health-related quality of life improvement.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in Bristol stool form scale score
Change from baseline in Bristol Stool Form Scale (BSFS) score. The unabbreviated scale name is Bristol Stool Form Scale; individual raw scores range from 1 to 7. Higher raw BSFS scores represent looser stool consistency.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Subjective product evaluation questionnaire score
Total score from the Subjective Product Evaluation Questionnaire, a study-specific questionnaire containing 12 items to assess participants' subjective perception and satisfaction with the investigational product. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 12 to 60; higher total scores indicate greater perceived improvement and higher satisfaction with the investigational product.
Measured: 4, 8 and 12 weeks after intervention
Change in hip circumference
Change from baseline in hip circumference, to assess central obesity improvement.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in waist-to-height ratio
Change from baseline in waist-to-height ratio, to assess central obesity improvement.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in waist-to-hip ratio
Change from baseline in waist-to-hip ratio, to assess central obesity improvement.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in body fat percentage
Change from baseline in body fat percentage, to assess body fat improvement.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in body mass index (BMI)
Change from baseline in body mass index (BMI), to assess body fat improvement.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in basal metabolic rate calculated by Nelson formula
Change from baseline in basal metabolic rate calculated by Nelson formula, derived from body fat percentage, to assess changes in resting energy consumption.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Change in fasting insulin
Change from baseline in fasting insulin, to evaluate glucose metabolism status.
Measured: Baseline and 12 weeks after intervention
Change in triglyceride
Change from baseline in triglyceride, to evaluate lipid metabolism status.
Measured: Baseline and 12 weeks after intervention
Change in total cholesterol
Change from baseline in total cholesterol, to evaluate lipid metabolism status.
Measured: Baseline and 12 weeks after intervention
Change in low-density lipoprotein cholesterol (LDL-C)
Change from baseline in low-density lipoprotein cholesterol (LDL-C), to evaluate lipid metabolism status.
Measured: Baseline and 12 weeks after intervention
Change in high-density lipoprotein cholesterol (HDL-C)
Change from baseline in high-density lipoprotein cholesterol (HDL-C), to evaluate lipid metabolism status.
Measured: Baseline and 12 weeks after intervention
Change in apolipoprotein B
Change from baseline in apolipoprotein B, to evaluate lipid metabolism status.
Measured: Baseline and 12 weeks after intervention
Change in IBS Symptom Severity Scale (IBS-SSS) score
Change from baseline in IBS Symptom Severity Scale (IBS-SSS) score. Scores range from 0 to 500; higher scores indicate more severe IBS symptoms, to evaluate the severity of intestinal symptoms.
Measured: Baseline, 4, 8 and 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start12 Jul 2026
- Primary completion17 Oct 2026 (estimated)
- Study completion17 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884643
- Sponsor's protocol ID
- W26002003
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-Week Solid Beverage Intervention on Suboptimal Health Status
- ClinicalTrials.gov ID
- NCT07884643
- Acronym / sponsor ID
- W26002003
- Conditions
- Metabolic Disorder, Sub-health Status
- Keywords
- Metabolic Disorders, Sub-health Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2026 (actual)
- Primary completion
- 17 Oct 2026 (estimated)
- Study completion
- 17 Oct 2026 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Meta Solid Beverage ASubjects consume the investigational solid beverage containing postbiotics BPL1, *Aronia melanocarpa* fruit extract, apple polyphenols, D-allulose, inulin, lutein and other ingredients. |
| Placebo Control Arm | Placebo comparator | Other: Meta Solid Beverage BSubjects consume placebo solid beverage. The placebo has identical appearance, taste and packaging to the investigational product, but does not contain the above active ingredients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age: 18-60 years, no gender restriction;
- BMI ≥ 25.0 kg/m² (mandatory criterion);
- 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):
- Voluntary participation: Signed informed consent form and willingness to comply with study procedures.
Key exclusion criteria (13 listed)
- Confirmed diagnosed diseases: diabetes mellitus, hypertension, drug-treated hyperlipidemia, coronary heart disease, cerebrovascular diseases, etc.
- Biochemical indicators reaching diagnostic thresholds (corresponding to the above inclusion indicators; subjects will be excluded if any single indicator meets the threshold):
- Concurrent use of metabolism-affecting medications: hypoglycemic agents, lipid-lowering drugs (statins, fibrates), weight-loss drugs, glucocorticoids, etc.
- 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.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meta Solid Beverage ASolid 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. | Other | Intervention Arm |
| Meta Solid Beverage BPlacebo 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. | Other | Placebo Control Arm |
Primary outcome
Change in Metabolic Syndrome Risk Index (MetS)
Time frame: 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.
22 secondary outcomes
Change in waist circumference
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in basal metabolic rate calculated by Cunningham formula
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in fasting blood glucose
Time frame: Baseline and 12 weeks after intervention
Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)
Time frame: Baseline and 12 weeks after intervention
Change in systolic blood pressure and diastolic blood pressure
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in palm skin surface temperature
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in SF-36 health survey summary score
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in Bristol stool form scale score
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Subjective product evaluation questionnaire score
Time frame: 4, 8 and 12 weeks after intervention
Change in hip circumference
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in waist-to-height ratio
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in waist-to-hip ratio
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in body fat percentage
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in body mass index (BMI)
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in basal metabolic rate calculated by Nelson formula
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Change in fasting insulin
Time frame: Baseline and 12 weeks after intervention
Change in triglyceride
Time frame: Baseline and 12 weeks after intervention
Change in total cholesterol
Time frame: Baseline and 12 weeks after intervention
Change in low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline and 12 weeks after intervention
Change in high-density lipoprotein cholesterol (HDL-C)
Time frame: Baseline and 12 weeks after intervention
Change in apolipoprotein B
Time frame: Baseline and 12 weeks after intervention
Change in IBS Symptom Severity Scale (IBS-SSS) score
Time frame: Baseline, 4, 8 and 12 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta Solid Beverage A and Meta Solid Beverage B in people with Metabolic Disorder and Sub-health Status, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanwen Jiang (13501700841, jiangyanwen@china-norm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Metabolic Syndrome Risk Index (MetS) (time frame: Baseline and 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.