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RecruitingNCT07884643Updated Oct 20, 2026

Effects of a 12-Week Solid Beverage Intervention on Suboptimal Health Status

An interventional study of Meta Solid Beverage A and Meta Solid Beverage B in Metabolic Disorder and Sub-health Status, sponsored by ChinaNorm. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by ChinaNorm · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

  • Metabolic Disorder
  • Sub-health Status

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Keywords

  • Metabolic Disorders
  • Sub-health Status
03

In context

Metabolic Diseases

1,002 studies on the registry are indexed under Metabolic Diseases; 231 are open to participants now.

This study's planned enrollment of 70 is above the median of 48 across 673 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

ChinaNorm is the lead sponsor of 28 studies on the registry; 12 are open to participants now.

Browse ChinaNorm studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Intervention Arm

    Subjects consume the investigational solid beverage containing postbiotics BPL1, \*Aronia melanocarpa\* fruit extract, apple polyphenols, D-allulose, inulin, lutein and other ingredients.

    Other: Meta Solid Beverage A

  • Placebo comparator
    Placebo Control Arm

    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.

    Other: Meta Solid Beverage B

Interventions

  • OtherMeta 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.

  • OtherMeta 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks after intervention

Secondary outcomes

  1. Change in waist circumference

    Change from baseline in waist circumference, to assess central obesity improvement.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  2. 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.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  3. Change in fasting blood glucose

    Change from baseline in fasting blood glucose, to evaluate glucose metabolism status.

    Time frame: Baseline and 12 weeks after intervention

  4. 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.

    Time frame: Baseline and 12 weeks after intervention

  5. 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.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  6. 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.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  7. 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.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  8. 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.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  9. 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.

    Time frame: 4, 8 and 12 weeks after intervention

  10. Change in hip circumference

    Change from baseline in hip circumference, to assess central obesity improvement.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  11. Change in waist-to-height ratio

    Change from baseline in waist-to-height ratio, to assess central obesity improvement.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  12. Change in waist-to-hip ratio

    Change from baseline in waist-to-hip ratio, to assess central obesity improvement.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  13. Change in body fat percentage

    Change from baseline in body fat percentage, to assess body fat improvement.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  14. Change in body mass index (BMI)

    Change from baseline in body mass index (BMI), to assess body fat improvement.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  15. 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.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  16. Change in fasting insulin

    Change from baseline in fasting insulin, to evaluate glucose metabolism status.

    Time frame: Baseline and 12 weeks after intervention

  17. Change in triglyceride

    Change from baseline in triglyceride, to evaluate lipid metabolism status.

    Time frame: Baseline and 12 weeks after intervention

  18. Change in total cholesterol

    Change from baseline in total cholesterol, to evaluate lipid metabolism status.

    Time frame: Baseline and 12 weeks after intervention

  19. Change in low-density lipoprotein cholesterol (LDL-C)

    Change from baseline in low-density lipoprotein cholesterol (LDL-C), to evaluate lipid metabolism status.

    Time frame: Baseline and 12 weeks after intervention

  20. Change in high-density lipoprotein cholesterol (HDL-C)

    Change from baseline in high-density lipoprotein cholesterol (HDL-C), to evaluate lipid metabolism status.

    Time frame: Baseline and 12 weeks after intervention

  21. Change in apolipoprotein B

    Change from baseline in apolipoprotein B, to evaluate lipid metabolism status.

    Time frame: Baseline and 12 weeks after intervention

  22. 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.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

Other outcomes

  1. Skin carotenoid index

    Change from baseline in skin carotenoid index, an exploratory indicator for antioxidant defense assessment. It is measured by skin autofluorescence spectroscopy instrument to reflect skin antioxidant reserve level.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  2. Skin stratum corneum hydration and transepidermal water loss

    Change from baseline in skin stratum corneum hydration and transepidermal water loss, exploratory objective indicators for skin health evaluation.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  3. Skin status self-assessment questionnaire score

    Change from baseline in skin status self-assessment questionnaire score, exploratory subjective indicator for skin health evaluation.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  4. Digit Symbol Substitution Test accuracy, N-back task accuracy and Stroop color-word interference effect value

    Change from baseline in Digit Symbol Substitution Test accuracy, N-back task accuracy and Stroop color-word interference effect value, exploratory indicators to assess cognitive performance.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  5. Visual fatigue scale score

    Change from baseline in visual fatigue scale score, exploratory indicator for eye function assessment.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  6. Number of days with upper respiratory tract infection

    Number of days of upper respiratory tract infection during the study period, exploratory indicator for immune function assessment.

    Time frame: Baseline and throughout the 12-week intervention period

  7. Lifestyle questionnaire

    Data collected from lifestyle questionnaire at baseline and post-intervention, exploratory collection of participants' lifestyle information.

    Time frame: Baseline

  8. Skin advanced glycation end products

    Change from baseline in skin advanced glycation end products, an exploratory indicator for antioxidant defense assessment. Measured by AGE Reader via skin autofluorescence spectroscopy to assess accumulation of skin advanced glycation end products.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

  9. Skin erythema index

    Change from baseline in skin erythema index, an exploratory indicator for antioxidant defense assessment. Measured by Mexameter MX18 (Courage\&Khazaka, Germany) based on spectral absorption principle to evaluate skin redness and inflammatory status.

    Time frame: Baseline, 4, 8 and 12 weeks after intervention

07

Study locations

1 of 1 sites recruiting
  • Shanghai China-norm Quality Technical Service Co., Ltd.
    Shanghai, Shanghai Municipality 200072, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Oct 2026, 3 months after the start.

Of 318 interventional studies with no phase under Metabolic Diseases, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 20, 2026
StartActual
Jul 12, 2026
Primary completionEst.
Oct 17, 2026
CompletionEst.
Oct 17, 2026
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07884643
Lead sponsor
ChinaNorm
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Jul 12, 2026
Primary completion
Oct 17, 2026 (estimated)
Completion
Oct 17, 2026 (estimated)
Last update
Oct 20, 2026

Study contacts

Yanwen Jiang
Contact
jiangyanwen@china-norm.com
13501700841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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