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Metabolic SyndromeNCT06183801

Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.

A study testing Probiotics 1, Probiotics 2 and Probiotics 3 in people with Metabolic Syndrome, run by Glac Biotech Co., Ltd at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Read more about this study

Who is it for?
Any age
Conditions the study is for
Metabolic Syndrome
What is being tested?
Probiotics 1, Probiotics 2 and Probiotics 3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
1 siteTaiwan
Study dates
1 Aug 2021to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The subject are willing to provide physical examination reports within the past 1 year.
  • The subject are willing to sign informed consent form.

Who cannot join

  • Pregnant women or preparing for pregnancy.
  • The subject were taking antibiotics.
  • One of parents are not Han Chinese or aboriginal.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Glac Biotech Co., Ltd.

    Tainan, 74442

Other trials in Taiwan

About this study

Official title: GLAC Metabolic Regulatory Probiotics, the Evaluation to Improve the Human Metabolic Syndrome, Intestinal Microflora and Short Chain Fatty Acid.

The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated fromseveral aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.

Read the detailed description

In recent years, the issue of gut microbiota and probiotics has been becoming very popular, and more and more gastrointestinal health foods have been developed and commercialized. The impact of gut microbiota on human health has received increasing attention and expectations from the world. Probiotics are one of the most recognized and positive health materials for consumers. Lactobacillus/probiotics, the main raw materials of health foods most frequently purchased by domestic consumers in recent years, have always ranked the first. They have certain improvement effects in terms of gastrointestinal improvement, immune regulation, and blood lipid regulation. There are currently about 30 probiotic manufacturers in Taiwan. Since the regulations do not have any clinical functional requirements for probiotic products, most probiotic products only describe the characteristics, functions and animal experiments of probiotics. There is no actual clinical experimental data to verify the effect of probiotic products on human intestinal flora. The probiotics researched and developed by GLAC Biotechnology company have undergone rigorous in vitro and animal tests, and actively cooperate with domestic and foreign hospitals to conduct human clinical trials to verify the function of the strains.

With the progress of human culture and lifestyle, many diseases of modern civilization have emerged one after another. Most of these diseases are caused by changes of lifestyle or diet, leading to the human body's metabolic imbalances, such as high blood sugar, high cholesterol, hypertension, hyperuricemia, liver dysfunction, and obesity. Gut dysbiosis and diseases associated with aging usually have such phenomenon like increased pathogenic bacteria, decreased probiotics decrease and declined gut microbiota diversity. The gut dysbiosis contributes to the aging gut and aging-related diseases in at least three aspects including production of Lipopolysaccharides (LPS), reduced levels of short chain fatty acids (SCFAs), and inflamm-aging. The next generation sequencing (NGS) technology can provide high throughput, high sensitivity and reliable detection, and then the investigators can understand improving effects of the human gut microbiota. The Aging and Disease Prevention Research Center (ADPRC) of the Fooyin university has a complete and skilled next generation sequencing (NGS) platform and a gut microbiota database included 5000 clinical cases, and thus provide the best clinical verification platform for probiotic products. Based on the common probiotic/pathogenic markers, reported in most of studies, and 4 specific domestic markers found in our study, the investigators have defined the domestic gut aging index score (GAIS) to predict the aging of the gut. The GASI provides an excellent discrimination. In addition, gut microbiota normally affects inflammatory cytokines by generating SCFAs to modulate the immune system against pathogens. The improvement effects of GLAC biotech probiotics contains 5 specialized strains on the biochemical analysis and gut microbiota will be verified in the clinical trial through cooperation with the ADPRC. Through this project, the difference and improvement before and after the GLAC biotech probiotics taking will be clinically validated from several aspects, including blood biochemical values, NGS gut microbiota analysis, GAIS and SCFAs levels. Therefore, by this industry- academic cooperation project, the investigators can explore the improvement of human gut microbiota by GLAC biotech probiotics, to understand the essence of clinical benefit, and the investigators expect the accomplishments of this project can help the consumers understand the added value and excellence of the GLAC products, and thus enhance consumer confidence and expand product markets.

Being tested
Probiotics 1, Probiotics 2, Probiotics 3, Probiotics 4, Probiotics 5
Keywords
Probiotics, Gut microbiota, Metabolic imbalances, SCFAs
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotics 1Dietary supplement

    Subjects take probiotics capsule(Lactobacillus fermentum,TSF331) three times a day before meal.

  • Probiotics 2Dietary supplement

    Subjects take probiotics capsule(Lactobacillus reuteri,TSR332) three times a day before meal.

  • Probiotics 3Dietary supplement

    Subjects take probiotics capsule(Lactobacillus plantarum,TSP05) three times a day before meal.

  • Probiotics 4Dietary supplement

    Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05) three times a day before meal.

  • Probiotics 5Dietary supplement

    Subjects take probiotics capsule(Lactobacillus fermentum,TSF331+Lactobacillus reuteri,TSR332+Lactobacillus plantarum,TSP05+Postbiotics PE0401) three times a day before meal.

  • Placebo 1Dietary supplement

    Subjects take capsule three times a day before meal.

  • Probiotics 6Dietary supplement

    After 1 month wash out, subjects take probiotics capsule(Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.

  • Probiotics 7Dietary supplement

    After 1 month wash out, subjects take probiotics capsule(Lactobacillus rhamnosus, bv-77+Bifidobacterium animalis subsp. lactis,CP-9) three times a day before meal.

  • Placebo 2Dietary supplement

    After 1 month wash out, subjects take capsule three times a day before meal.

Study groups in NCT06183801
Study groupRoleWhat they receive
Probiotic 1ExperimentalSubjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Probiotics 1
Probiotic 2ExperimentalSubjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Probiotics 2
Probiotic 3ExperimentalSubjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Probiotics 3
Probiotic 4ExperimentalSubjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Probiotics 4
Probiotic 5ExperimentalSubjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Probiotics 5
Placebo 1Placebo comparatorSubjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Placebo 1
Probiotic 6ExperimentalAfter 1 month wash out,subjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Probiotics 6
Probiotic 7ExperimentalAfter 1 month wash out,subjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Probiotics 7
Placebo 2Placebo comparatorAfter 1 month wash out,subjects take probiotics capsule three times a day before meal.
Receives: Dietary Supplement: Placebo 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. blood biochemical indicators

    Detecting the changes of concentration in blood biochemical indexes .

    1. glucose AC (mg/dL)
    2. Glutamic Oxaloacetic Transaminase,GOT (U/L)
    3. Glutamic Pyruvic Transaminase,GPT (U/L)
    4. Blood urea nitrogen,BUN (mg/dL)
    5. Creatinine (mg/dL)
    6. Triglyceride,TG (mg/dL)
    7. total cholesterol (mg/dL)
    8. High-density lipoprotein,HDL (mg/dL)
    9. Low-density lipoprotein,LDL (mg/dL)

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

  2. Changes in gut microbiota ratios

    Using Next-Generation Sequencing (NGS) to analyze the changes of fecal flora.

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

  3. Changes in gut aging index score(GAIS)

    Calculating probiotic/pathogenic ratios

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

Secondary outcomes (5)
  1. Short chain fatty acid analysis

    Changerate of short chain fatty acid in stool

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

  2. Changes in sleep quality

    PITTSBURGH SLEEP QUALITY INDEX (PSQI):The minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.

    The change in score will be evaluated.

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

  3. Evaluating the score difference of Gastrointestinal(GI) symptoms questionnaire

    Gastrointestinal(GI) symptoms questionnaire:The minimum value is "0" and maximum value is "30", higher scores mean a worse outcome.The change in score will be evaluated.

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

  4. Evaluating the score difference of Physical symptoms questionnaire

    Physical symptoms questionnaire:The minimum value is "0" and maximum value is "75", higher scores mean a worse outcome.The change in score will be evaluated.

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

  5. Changes in stool form

    Record the stool form and color.Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.(Type 1: Separate hard lumps, like nuts (difficult to pass)、Type 2: Sausage-shaped, but lumpy、Type 3: Like a sausage but with cracks on its surface、Type 4: Like a sausage or snake, smooth and soft (average stool)、Type 5: Soft blobs with clear cut edges、Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea)、Type 7: Watery, no solid pieces, entirely liquid (diarrhea))

    Measured: Day0、Day30、Day60、Day90、Day120、Day180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2023
  2. Study start1 Aug 2021
  3. Primary completion30 Sep 2022
  4. Study completion31 Mar 2023

Resources

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
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06183801
Sponsor's protocol ID
FYH-IRB-110-01-02
Status last verified
Dec 2023
First submitted
4 Dec 2023
Last updated
28 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lin JH, Lin CH, Kuo YW, Liao CA, Chen JF, Tsai SY, Li CM, Hsu YC, Huang YY, Hsia KC, Yeh YT, Ho HH. Probiotic Lactobacillus fermentum TSF331, Lactobacillus reuteri TSR332, and Lactobacillus plantarum TSP05 improved liver function and uric acid management-A pilot study. PLoS One. 2024 Jul 24;19(7):e0307181. doi: 10.1371/journal.pone.0307181. eCollection 2024.

    PubMed 39046973

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics 1, Probiotics 2 and Probiotics 3 in people with Metabolic Syndrome, run by Glac Biotech Co., Ltd at 1 site in Taiwan.

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 3 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: finished, as of the sponsor's last update on 28 Dec 2023. 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

blood biochemical indicators (time frame: Day0、Day30、Day60、Day90、Day120、Day180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06183801, which also lists 1 linked publication.

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 28 Dec 2023.

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