Fatty LiverNCT06873412
Effects of Compound Probiotics-Polygonatum Sibiricum on Liver Health and Metabolism in Middle-aged and Elderly People
A study testing Probiotic and Placbo in people with Fatty Liver, run by Wecare Probiotics Co., Ltd..
Trial summary
The purpose of this study was to evaluate the regulatory effects of Huangqian-biobacteria compound preparation on liver health and related metabolic disorders in middle-aged and elderly people, observe its effects on liver function indexes, basal metabolic rate, markers of oxidative stress, inflammatory factors and… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- Probiotic and Placbo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2025to 1 Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The age of the subjects is 40-80 years old; 2. The subject meets one of the following metabolic disease components: ① abdominal B - ultrasound shows fatty liver or fat infiltration; ② arterial blood pressure is higher than 130/85mmHg, or the subject is on antihypertensive treatment; ③ prediabetes or type 2 diabetes, with fasting blood glucose above 6.1mmol/L; ④ overweight or obesity, with BMI of 24.0kg/m² or more, or male waist circumference of 90cm or more, female waist circumference of 85cm or more, or excessive body fat content and percentage.
- -
Who cannot join
- People who are allergic to any of the pharmaceutical ingredients used in this study; A history of alcohol abuse (drinking more than 14 units of alcohol per week :1 unit = 285mL for beer, 25mL for spirits, 100mL for wine);
- Patients who received probiotics within 1 month before taking the experimental drug;
- Recent history of gastrointestinal bleeding, obstruction, perforation, tumor and other serious organic diseases;
- Aminotransferase index > 3 times the normal value;
- Kidney disease (creatinine index higher than normal);
- Patients with serious psychological and mental diseases, resulting in the inability to express themselves normally;
- Patients with infectious liver diseases, such as hepatitis B and C;
- The female subject is breastfeeding or has a positive pregnancy test result during the screening period or during the test -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Regulatory Effect of Probiotics-Polygonatum Sibiricum on Liver Health and Metabolic Disorders in Middle-Aged and Elderly People: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
The purpose of this study was to evaluate the regulatory effects of Huangqian-biobacteria compound preparation on liver health and related metabolic disorders in middle-aged and elderly people, observe its effects on liver function indexes, basal metabolic rate, markers of oxidative stress, inflammatory factors and intestinal microecology, and evaluate the incidence of adverse reactions in subjects during the 3-month intervention period.
- Conditions
- Fatty Liver
- Being tested
- Probiotic, Placbo
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3).
PlacboDietary supplement
The experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Intervention group of polygonatum-probiotics complex, take 1 piece (2.0 g) daily Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | maltodextrin, take 1 piece (2.0 g) daily Receives: Dietary Supplement: Placbo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alanine aminotransferase (ALT) levels
ALT level decline indicates improved liver function, assessed via blood tests.
Measured: 3 months
Changes in aspartate aminotransferase (AST) levels
AST level decline indicates improved liver function, assessed via blood tests.
Measured: 3 months
Secondary outcomes (21)
Changes in basal metabolic rate
The Mifflin-St Jeor equation was used to evaluate the subject's basal metabolic level, reflecting the body's energy expenditure at rest.
Measured: 3 months
Metabolic index
Blood pressure: Evaluate the effects of the tested product on age-related cardiovascular health and monitor changes in systolic and diastolic blood pressure.
Measured: 3 months
Gamma-glutamyltransferase (GGT)
Evaluate the effects of the tested product on liver-related components. GGT: The unit is U/L.
Measured: 3 months
Total bilirubin (TBil)
Evaluate the effects of the tested product on liver-related components. TBil: Unit: μmol/L.
Measured: 3 months
Uric acid
Evaluate the effects of the tested product on liver-related components. Uric acid: unit: μmol/L.
Measured: 3 months
Weight
Evaluate the effects of the tested product on body weight. Weight: Unit: kg.
Measured: 3 months
BMI (body mass index)
The effects of the product on body mass index were evaluated. BMI: Unit: kg/m².
Measured: 3 months
Fasting blood glucose
Evaluate the effect of the tested product on blood sugar levels. Fasting blood glucose: the unit is mmol/L.
Measured: 3 months
Total cholesterol
The effect of the tested product on lipid levels was evaluated. Total cholesterol: Unit: mmol/L.
Measured: 3 months
Triglyceride
The effect of the tested product on lipid levels was evaluated. Triglyceride: The unit is mmol/L.
Measured: 3 months
Low-density lipoprotein (LDL)
The effect of the tested product on lipid levels was evaluated. LDL: The unit is mmol/L.
Measured: 3 months
High density lipoprotein (HDL)
The effect of the tested product on lipid levels was evaluated. HDL: The unit is mmol/L.
Measured: 3 months
Changes in malondialdehyde (MDA) levels
Evaluate the effects of test products on oxidative stress levels. MDA: The unit is μmol/L.
Measured: 3 months
Changes in the level of superoxide dismutase (SOD)
Evaluate the effects of test products on oxidative stress levels. SOD: The unit is U/mL.
Measured: 3 months
Changes in glutathione (GSH) levels
Evaluate the effects of test products on oxidative stress levels. GSH: Unit: μmol/L
Measured: 3 months
Fatigue Severity Scale (FSS)
Evaluate the fatigue severity of the tested product. FSS score: The unit is points, ranging from 1 to 7 points.
1 score: No fatigue Score 7: Extreme fatigue Higher score: indicates more severe fatigue
Measured: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Participants' overall sleep quality over the past three months was assessed. PSQI score: The unit is points, ranging from 0 to 21 points. 0 score: Best sleep quality 21 points: worst sleep quality Higher score: indicates poorer sleep quality
Measured: 3 months
Short-chain fatty acids (SCFAs)
hort-chain fatty acids: Short-chain fatty acids such as acetic acid, propionic acid, and butyric acid are analyzed in stool samples by gas chromatography-mass spectrometry (GC-MS) or high performance liquid chromatography (HPLC).
Acetic acid: unit: μmol/g fecal matter. Propionic acid: The unit is μmol/g feces. Butyric acid: The unit is μmol/g feces.
Measured: 3 months
Fecal flora structure (16S rRNA sequencing)
16S rRNA sequencing: Bacterial 16S rRNA genes in fecal samples are analyzed by high-throughput sequencing techniques to determine the diversity and composition of the gut microbiota.
Diversity index: such as Shannon index, Chao1 index, etc., used to measure the diversity of flora.
Composition analysis: The relative abundance of major bacterial phyla, genera and species is determined by taxonomic analysis.
Measured: 3 months
Inflammatory factor
Changes in serum levels of inflammatory cytokines (IL-6, IL-1β, TNF-α, IP-10) : To evaluate the effect of the tested product on the inflammatory response and reflect the immune status of the body.
Measured: 3 months
Fatty liver morphology
Abdominal B-ultrasound: To evaluate the effect of the tested product on the morphology of fatty liver, reflecting the liver fat deposition.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873412
- Sponsor's protocol ID
- WK20250302
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regulatory Effect of Probiotics-Polygonatum Sibiricum on Liver Health and Metabolic Disorders in Middle-Aged and Elderly People: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06873412
- Acronym / sponsor ID
- WK20250302
- Conditions
- Fatty Liver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Mar 2025 (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.
The purpose of this study was to evaluate the regulatory effects of Huangqian-biobacteria compound preparation on liver health and related metabolic disorders in middle-aged and elderly people, observe its effects on liver function indexes, basal metabolic rate, markers of oxidative stress, inflammatory factors and intestinal microecology, and evaluate the incidence of adverse reactions in subjects during the 3-month intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: ProbioticIntervention group of polygonatum-probiotics complex, take 1 piece (2.0 g) daily |
| Placebo group | Placebo comparator | Dietary Supplement: Placbomaltodextrin, take 1 piece (2.0 g) daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. The age of the subjects is 40-80 years old; 2. The subject meets one of the following metabolic disease components: ① abdominal B - ultrasound shows fatty liver or fat infiltration; ② arterial blood pressure is higher than 130/85mmHg, or the subject is on antihypertensive treatment; ③ prediabetes or type 2 diabetes, with fasting blood glucose above 6.1mmol/L; ④ overweight or obesity, with BMI of 24.0kg/m² or more, or male waist circumference of 90cm or more, female waist circumference of 85cm or more, or excessive body fat content and percentage.
- -
Key exclusion criteria (8 listed)
- People who are allergic to any of the pharmaceutical ingredients used in this study; A history of alcohol abuse (drinking more than 14 units of alcohol per week :1 unit = 285mL for beer, 25mL for spirits, 100mL for wine);
- Patients who received probiotics within 1 month before taking the experimental drug;
- Recent history of gastrointestinal bleeding, obstruction, perforation, tumor and other serious organic diseases;
- Aminotransferase index > 3 times the normal value;
- Kidney disease (creatinine index higher than normal);
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 |
|---|---|---|
| ProbioticThe experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3). | Dietary supplement | Probiotic group |
| PlacboThe experimental phase of the study will last for 3 months, and each subject will be followed up 3 times (month 0, Month 1, Month 2, month 3). | Dietary supplement | Placebo group |
Primary outcome
Changes in alanine aminotransferase (ALT) levels
Time frame: 3 months
ALT level decline indicates improved liver function, assessed via blood tests.
Changes in aspartate aminotransferase (AST) levels
Time frame: 3 months
AST level decline indicates improved liver function, assessed via blood tests.
21 secondary outcomes
Changes in basal metabolic rate
Time frame: 3 months
Metabolic index
Time frame: 3 months
Gamma-glutamyltransferase (GGT)
Time frame: 3 months
Total bilirubin (TBil)
Time frame: 3 months
Uric acid
Time frame: 3 months
Weight
Time frame: 3 months
BMI (body mass index)
Time frame: 3 months
Fasting blood glucose
Time frame: 3 months
Total cholesterol
Time frame: 3 months
Triglyceride
Time frame: 3 months
Low-density lipoprotein (LDL)
Time frame: 3 months
High density lipoprotein (HDL)
Time frame: 3 months
Changes in malondialdehyde (MDA) levels
Time frame: 3 months
Changes in the level of superoxide dismutase (SOD)
Time frame: 3 months
Changes in glutathione (GSH) levels
Time frame: 3 months
Fatigue Severity Scale (FSS)
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
Short-chain fatty acids (SCFAs)
Time frame: 3 months
Fecal flora structure (16S rRNA sequencing)
Time frame: 3 months
Inflammatory factor
Time frame: 3 months
Fatty liver morphology
Time frame: 3 months
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 12 Mar 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Placbo in people with Fatty Liver, run by Wecare Probiotics Co., Ltd..
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Bu Shurui (18930809609, 18930819609@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in alanine aminotransferase (ALT) levels (time frame: 3 months). The study lists 2 primary outcomes in all. 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 12 Mar 2025.