Overweight or ObesityNCT06653101
Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects
A study testing Probiotic in people with Overweight or Obesity, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 20 Mar 2025
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years old;
- BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
- Normal liver function indexes;
- Willing to complete study-related questionnaires and diaries and complete all clinical visits.
Who cannot join
- Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test;
- Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies;
- Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.;
- Recently treated with antibiotics (i.e., < 3 months prior to the start of the study);
- Participants who smoked more than 10 cigarettes per day were excluded;
- It is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products;
- Pregnant and lactating women are not suitable for experiments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects: a Randomized, Double-blind, Placebo-controlled Trial
To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.
- Conditions
- Overweight or Obesity
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)
PlaceboDietary supplement
The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Each Akk11 capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio), together with 1 × 10¹⁰ AFU of viable Akk11 cells. Dosage: 3 capsules per day. Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Each placebo capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio). Dosage: 3 capsules per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention.
Detected by enzyme-linked immunosorbent assay (ELISA).
Measured: week 0 and week 8
Changes in serum concentrations of leptin before and after intervention.
Detected by enzyme-linked immunosorbent assay (ELISA).
Measured: week 0 and week 8
Changes in serum concentrations of peptide YY before and after intervention.
Detected by enzyme-linked immunosorbent assay (ELISA).
Measured: week 0 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Oct 2024
- Primary completion5 Dec 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
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
- NCT06653101
- Sponsor's protocol ID
- WK2024014
- Status last verified
- Dec 2024
- First submitted
- 16 Oct 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06653101
- Acronym / sponsor ID
- WK2024014
- Conditions
- Overweight or Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 22 Oct 2024 (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.
To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: ProbioticEach Akk11 capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio), together with 1 × 10¹⁰ AFU of viable Akk11 cells. Dosage: 3 capsules per day. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboEach placebo capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio). Dosage: 3 capsules per day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-45 years old;
- BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
- Normal liver function indexes;
- Willing to complete study-related questionnaires and diaries and complete all clinical visits.
Key exclusion criteria (7 listed)
- Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test;
- Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies;
- Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.;
- Recently treated with antibiotics (i.e., < 3 months prior to the start of the study);
- Participants who smoked more than 10 cigarettes per day were excluded;
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 trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8) | Dietary supplement | Probiotic group |
| PlaceboThe trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8) | Dietary supplement | Placebo group |
Primary outcome
Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention.
Time frame: week 0 and week 8
Detected by enzyme-linked immunosorbent assay (ELISA).
Changes in serum concentrations of leptin before and after intervention.
Time frame: week 0 and week 8
Detected by enzyme-linked immunosorbent assay (ELISA).
Changes in serum concentrations of peptide YY before and after intervention.
Time frame: week 0 and week 8
Detected by enzyme-linked immunosorbent assay (ELISA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Overweight or Obesity, run by Wecare Probiotics Co., Ltd. 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 4 inclusion and 7 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 18 Nov 2025. 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?
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?
Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention. (time frame: week 0 and week 8). 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?
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 18 Nov 2025.