The Effect of Intervention With Probiotic K56 on Body Fat Reduction in Obese Subjects
NCT ID: NCT05192811
Last Updated: 2022-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-11-18
2022-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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probiotic K56
Probiotic capsule (lactobacillus paracasei K56 10\^9CFU) 1capsule/day , for 60days
Lactobacillus paracasei K56
probiotic K56 capsule, 1capsule/day (10\^9cfu) ,for 60days
placebo
placebo capsule(maltodextrin, 1capsule/day, 60days
placebo
placebo capsule(maltodextrin) , 1capsule/day ,for 60days
Interventions
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Lactobacillus paracasei K56
probiotic K56 capsule, 1capsule/day (10\^9cfu) ,for 60days
placebo
placebo capsule(maltodextrin) , 1capsule/day ,for 60days
Eligibility Criteria
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Inclusion Criteria
（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
Exclusion Criteria
* 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
* 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
40 Years
65 Years
ALL
Yes
Sponsors
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Inner Mongolia Yili Industrial Group Co., Ltd
INDUSTRY
Fudan University
OTHER
Responsible Party
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Zhijun Bao
Director
Principal Investigators
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Ying Feng, Ph.D
Role: STUDY_DIRECTOR
Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China
Locations
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Hua Dong Hospital Affiliated to Fu Dan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20210084
Identifier Type: -
Identifier Source: org_study_id
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