ObesityNCT05192811
The Effect of Intervention With Probiotic K56 on Body Fat Reduction in Obese Subjects
A study testing Lactobacillus paracasei K56 in people with Obesity, run by Fudan University at 1 site in China.
Trial summary
The aim of the present study was to investigate the effect of intervention with Lactobacillus paracasei K56 on body fat, metabolic risk markers,inflammatory markers and gut microbiota composition in obesity. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Lactobacillus paracasei K56
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2021to 1 Dec 2022
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obesity : BMI>=30kg/m2,or percent body fat(PBF) >=25% for male, >=30% for female.
- （Note: If PBF was eligible, it was recommended that 26 ≤ BMI ≤ 40）
- Age: 40 - 65 years old adults
- Who has the conditions to preserve the test samples at low temperature throughout the whole process
Who cannot join
- Patients with severe chronic diseases（heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental illness and organ surgery history, etc.) and complications;
- Patients with severe allergy and immunodeficiency;
- Patients with a clear history of gastrointestinal diseases (ulcer, irritable bowel syndrome, etc.);
- History of intervention with fat-reducing drugs or health products in the past 2 months
- Take weight control measures (diet, exercise, etc.) within the past month
- Participation in other clinical trials within the past 3 months
Show all 9Show fewer
- who have used antibiotics in the past 2weeks ;
- Those who cannot guarantee to maintain their current lifestyle during the trial period
- Those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hua Dong Hospital Affiliated to Fu Dan University
Shanghai
Ying Feng, Ph.D, +86 18121221972, yingfenghd@hotmail.com
About this study
Official title: Evaluation of the Effects of a Probiotic Strain Lactobacillus Paracasei K56 on Body Fat Reduction in Middle-aged Obese Subjects：A Randomized, Double-Blind, Placebo-Controlled Trial
The aim of the present study was to investigate the effect of intervention with Lactobacillus paracasei K56 on body fat, metabolic risk markers,inflammatory markers and gut microbiota composition in obesity.
Read the detailed description
Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.
In this randomised,double blind ,placebo controlled study, the participants were randomly assigned to probiotic K56 group or placebo group to evaluate the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing probiotic or placebo capsules.
- Conditions
- Obesity
- Being tested
- Lactobacillus paracasei K56, placebo
- Keywords
- obesity, lactobacillus paracasei, body fat, visceral fat area, gut microbiota
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei K56Dietary supplement
probiotic K56 capsule, 1capsule/day (10^9cfu) ,for 60days
placeboDietary supplement
placebo capsule(maltodextrin) , 1capsule/day ,for 60days
| Study group | Role | What they receive |
|---|---|---|
| probiotic K56 | Experimental | Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days Receives: Dietary Supplement: Lactobacillus paracasei K56 |
| placebo | Placebo comparator | placebo capsule(maltodextrin, 1capsule/day, 60days Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral fat area (cm^2)
VFA (cm^2) will be assessed at baseline and after 60days of intervention
Measured: 60days
percent body fat (%)
PBF (%) will be assessed at baseline and after 60days of intervention
Measured: 60days
Secondary outcomes (9)
body weight
Body weight (kg) will be assessed at baseline and after 60days of intervention
Measured: 60days
Body Mass Index BMI
Body Mass Index (kg/m^2) will be assessed at baseline and after 60days of intervention
Measured: 60 days
waist circumference (cm)
will be assessed at baseline and after 60days of intervention
Measured: Baseline, 60 days
hip circumference(cm)
will be assessed at baseline and after 60days of intervention
Measured: 60 days
waist to hip ratio (WHR)
waist to hip ratio (WHR) will be assessed at baseline and after 60days of intervention
Measured: 60 days
Serum Lipid Profile
Serum total cholesterol(mmol/L)，Serum triglycerides(mmol/L)，Low-density lipoprotein(mmol/L)，High density lipoprotein(mmol/L) will be measured at baseline and after 60days of intervention
Measured: 60 days
fasting blood glucose
fasting blood glucose(mmol/L) will be measured at baseline and after 60days of intervention
Measured: 60 days
Glycated hemoglobin
Glycated hemoglobin(%) will be measured at baseline and after 60days of intervention
Measured: 60 days
Glycosylated albumin
Glycosylated albumin(%) will be measured at baseline and after 60days of intervention
Measured: 60days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start18 Nov 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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 Fudan UniversityThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia Yili Industrial Group Co., Ltd
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
- Investigators
- Ying Feng, Ph.D, Study director, Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192811
- Sponsor's protocol ID
- 20210084
- Status last verified
- Nov 2021
- First submitted
- 13 Dec 2021
- Last updated
- 14 Jan 2022
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of a Probiotic Strain Lactobacillus Paracasei K56 on Body Fat Reduction in Middle-aged Obese Subjects：A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05192811
- Acronym / sponsor ID
- 20210084
- Conditions
- Obesity
- Keywords
- obesity, lactobacillus paracasei, body fat, visceral fat area, gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Inner Mongolia Yili Industrial Group Co., Ltd
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 14 Jan 2022 (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 aim of the present study was to investigate the effect of intervention with Lactobacillus paracasei K56 on body fat, metabolic risk markers,inflammatory markers and gut microbiota composition in obesity.
Detailed description
Recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.The results of previous animal studies have suggest that a probiotic strain Lactobacillus paracasei K56 have reduced high-fat diet induced obesity.
In this randomised,double blind ,placebo controlled study, the participants were randomly assigned to probiotic K56 group or placebo group to evaluate the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing probiotic or placebo capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic K56 | Experimental | Dietary Supplement: Lactobacillus paracasei K56Probiotic capsule (lactobacillus paracasei K56 10^9CFU) 1capsule/day , for 60days |
| placebo | Placebo comparator | Dietary Supplement: placeboplacebo capsule(maltodextrin, 1capsule/day, 60days |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obesity : BMI>=30kg/m2,or percent body fat(PBF) >=25% for male, >=30% for female.
- （Note: If PBF was eligible, it was recommended that 26 ≤ BMI ≤ 40）
- Age: 40 - 65 years old adults
- Who has the conditions to preserve the test samples at low temperature throughout the whole process
Key exclusion criteria (9 listed)
- Patients with severe chronic diseases（heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental illness and organ surgery history, etc.) and complications;
- Patients with severe allergy and immunodeficiency;
- Patients with a clear history of gastrointestinal diseases (ulcer, irritable bowel syndrome, etc.);
- History of intervention with fat-reducing drugs or health products in the past 2 months
- Take weight control measures (diet, exercise, etc.) within the past month
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 |
|---|---|---|
| Lactobacillus paracasei K56probiotic K56 capsule, 1capsule/day (10^9cfu) ,for 60days | Dietary supplement | probiotic K56 |
| placeboplacebo capsule(maltodextrin) , 1capsule/day ,for 60days | Dietary supplement | placebo |
Primary outcome
visceral fat area (cm^2)
Time frame: 60days
VFA (cm^2) will be assessed at baseline and after 60days of intervention
percent body fat (%)
Time frame: 60days
PBF (%) will be assessed at baseline and after 60days of intervention
9 secondary outcomes
body weight
Time frame: 60days
Body Mass Index BMI
Time frame: 60 days
waist circumference (cm)
Time frame: Baseline, 60 days
hip circumference(cm)
Time frame: 60 days
waist to hip ratio (WHR)
Time frame: 60 days
Serum Lipid Profile
Time frame: 60 days
fasting blood glucose
Time frame: 60 days
Glycated hemoglobin
Time frame: 60 days
Glycosylated albumin
Time frame: 60days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Ying Feng, Ph.D study director
Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus paracasei K56 in people with Obesity, run by Fudan University 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Feng, Ph.D (+86 18121221972, yingfenghd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visceral fat area (cm^2) (time frame: 60days). 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 14 Jan 2022.