Effects of BLa80 and LRa05 on the Gut Microbiota Metabolite Profile of Healthy Individuals

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorWecare Probiotics Co., Ltd.

About this trial

Gut microbiota play a key role in polyphenol metabolism, participating in the breakdown of dietary components and producing various small molecule metabolites that affect human health. However, little is currently known about how gut microbes metabolize dietary compounds and produce bioactive metabolites. This study aims to use metabolomics to precisely identify food-derived metabolites in the blood to investigate whether probiotics (BLa80, LRa05) can enhance the breakdown of dietary components and improve their absorption and utilization in the human body.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female participants aged 18 to 60 years;

Healthy individuals;

Participants must provide written informed consent.

Disqualifiers

History of gastrointestinal surgery, other gastrointestinal diseases, metabolic disorders, immunodeficiency, hyperthyroidism, or cardiac or liver disease;

Use of immunosuppressants;

Pregnant or breastfeeding women;

Participants who have taken antibiotics or probiotics within the previous 3 months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Dietary supplement

    The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

  • BLa80

    Dietary supplement

    The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

  • LRa05

    Dietary supplement

    The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).

Treatment groups

375 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: BLa80Experimental treatment 1 intervention
Group C: LRa05Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum metabolomic profiles measured by HPLC-MS/MS

Untargeted serum metabolomic profiling will be performed using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to assess changes in circulating metabolite concentrations over time.

Time frame
Baseline (week 0), week 4, and week 8 post intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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