ObesityNCT06964919
Research on Probiotics in Improving Obesity
A study testing Probiotic in people with Obesity, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low … Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- 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
- 61 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2025to 20 Jan 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A body mass index (BMI) of ≥24 kg/m²;
- Willingness to provide written informed consent to participate in the study;
- Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet;
- No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.
Who cannot join
- Use of products similar to the test product in the near term that may affect the results;
- Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies;
- Pregnant, breastfeeding, or planning pregnancy;
- Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
- Antibiotic use within the past three months;
- Failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible;
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- Smoking more than 10 cigarettes a day;
- Allergy to probiotic products;
- Other participants deemed unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The School of Food and Bioengineering, Henan University of Science and Technolog
Luoyang, Henan, 471000
About this study
Official title: Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 for Weight and Energy Metabolism in Obesity/Overweight: a Randomized, Double-blind, Placebo-controlled Trial
Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/obese adults.
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 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)
PlaceboDietary supplement
The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Pasteurized Akkermansia muciniphila Akk11 capsule, 10 billion TFU/day Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Placebo capsule, one capsules/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight before and after intervention
Measured using a calibrated scale
Measured: Week 0 , Week 4, Week 8, Week 12
Change in BMI before and after intervention
Measured using a calibrated scale and stadiometer
Measured: Week 0 , Week 4, Week 8, Week 12
Change in waist-hip ratio (WC) before and after intervention
Measured using a non-elastic measuring tape
Measured: Week 0 , Week 4, Week 8, Week 12
Change in wrist circumference before and after intervention
Measured using a non-elastic measuring tape
Measured: Week 0 , Week 4, Week 8, Week 12
Change in visceral fat area before and after intervention.
Measured using bioelectrical impedance analysis (BIA)
Measured: Week 0 , Week 4, Week 8, Week 12
Change in basal metabolic rate (BMR) before and after intervention
Measured using indirect calorimetry
Measured: Week 0 , Week 4, Week 8, Week 12
Change in serum total cholesterol (TC) concentration before and after intervention
Detected by enzyme-linked immunosorbent assay (ELISA)
Measured: Week 0 and Week 12
Change in low-density lipoprotein (LDL) concentration before and after intervention
Detected by enzyme-linked immunosorbent assay (ELISA)
Measured: Week 0 and Week 12
Change in high-density lipoprotein (HDL) concentration before and after intervention
Detected by enzyme-linked immunosorbent assay (ELISA)
Measured: Week 0 and Week 12
Change in triglyceride (TG) concentration before and after intervention.
Detected by enzyme-linked immunosorbent assay (ELISA)
Measured: Week 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start10 Mar 2025
- Primary completion30 Dec 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 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
- NCT06964919
- Sponsor's protocol ID
- WK20250421
- Status last verified
- Jan 2026
- First submitted
- 22 Apr 2025
- Last updated
- 29 Jan 2026
- 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 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 for Weight and Energy Metabolism in Obesity/Overweight: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06964919
- Acronym / sponsor ID
- WK20250421
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 11 May 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.
Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/obese adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: ProbioticPasteurized Akkermansia muciniphila Akk11 capsule, 10 billion TFU/day |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule, one capsules/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A body mass index (BMI) of ≥24 kg/m²;
- Willingness to provide written informed consent to participate in the study;
- Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet;
- No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.
Key exclusion criteria (9 listed)
- Use of products similar to the test product in the near term that may affect the results;
- Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies;
- Pregnant, breastfeeding, or planning pregnancy;
- Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
- Antibiotic use within the past three months;
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 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12) | Dietary supplement | Probiotic group |
| PlaceboThe trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12) | Dietary supplement | Placebo group |
Primary outcome
Change in body weight before and after intervention
Time frame: Week 0 , Week 4, Week 8, Week 12
Measured using a calibrated scale
Change in BMI before and after intervention
Time frame: Week 0 , Week 4, Week 8, Week 12
Measured using a calibrated scale and stadiometer
Change in waist-hip ratio (WC) before and after intervention
Time frame: Week 0 , Week 4, Week 8, Week 12
Measured using a non-elastic measuring tape
Change in wrist circumference before and after intervention
Time frame: Week 0 , Week 4, Week 8, Week 12
Measured using a non-elastic measuring tape
Change in visceral fat area before and after intervention.
Time frame: Week 0 , Week 4, Week 8, Week 12
Measured using bioelectrical impedance analysis (BIA)
Change in basal metabolic rate (BMR) before and after intervention
Time frame: Week 0 , Week 4, Week 8, Week 12
Measured using indirect calorimetry
Change in serum total cholesterol (TC) concentration before and after intervention
Time frame: Week 0 and Week 12
Detected by enzyme-linked immunosorbent assay (ELISA)
Change in low-density lipoprotein (LDL) concentration before and after intervention
Time frame: Week 0 and Week 12
Detected by enzyme-linked immunosorbent assay (ELISA)
Change in high-density lipoprotein (HDL) concentration before and after intervention
Time frame: Week 0 and Week 12
Detected by enzyme-linked immunosorbent assay (ELISA)
Change in triglyceride (TG) concentration before and after intervention.
Time frame: Week 0 and Week 12
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 29 Jan 2026.
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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 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 9 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 29 Jan 2026. 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?
Change in body weight before and after intervention (time frame: Week 0 , Week 4, Week 8, Week 12). The study lists 10 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 29 Jan 2026.