Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study
1 other identifier
interventional
118
1 country
1
Brief Summary
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 before-after pilot study, the participants were randomly assigned to 8 groups to compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously supplementing different product prototypes , and screen the best probiotic K56 prototype with the effect of fat reduction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jan 2021
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2021
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 10, 2023
July 1, 2021
8 months
July 8, 2021
January 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
percent body fat
percent body fat (%) will be assessed at baseline and after 60days of intervention
60days
visceral fat area
visceral fat area (cm\^2) will be assessed at baseline and after 60days of intervention
60days
Secondary Outcomes (8)
Serum Lipid Profile
60 days
fasting blood glucose
60 days
Glycated hemoglobin
60 days
Glycosylated albumin
60 days
skeletal muscle mass
60 days
- +3 more secondary outcomes
Study Arms (8)
K56 very high dose -E1
ACTIVE COMPARATORProbiotic drink (lactobacillus paracasei K56 10\^11CFU) 350ml/d , for 60days
control -E2
PLACEBO COMPARATORmaltodextrin , for 60days
K56 high dose-E3
ACTIVE COMPARATORProbiotic powder 1.5g/sachet , 3.0g/d (lactobacillus paracasei K56 10\^10cfu) , for 60days
K56 middle dose-E5
ACTIVE COMPARATORProbiotic powder 8.0g/sachet , 8g/d ( Lactobacillus paracasei K56 10\^9cfu) , for 60days
K56 low dose -E7
ACTIVE COMPARATORprobiotic k56 capsule, 2capsules/d ( Lactobacillus paracasei K56 10\^7cfu) , for 60days
K56 middle dose-E9
ACTIVE COMPARATORprobiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10\^9cfu) ,for 60days
K56 high dose-E1K
ACTIVE COMPARATORprobiotic K56 capsule, 2capsules/d (Lactobacillus paracasei K56 10\^10cfu), for 60days
K56 very high dose-E11
ACTIVE COMPARATORprobiotic K56 capsule, 4capsules/d (Lactobacillus paracasei K56 10\^11cfu) ,for 60days
Interventions
Probiotic drink (K56 10\^11CFU) 350ml/d for 60days
Probiotic powder 3.0g/d (K56 10\^10cfu) 60days;
probiotic k56 capsule, 2capsules/d (10\^7cfu) for 60days
probiotic k56 capsule, 2capsules/d (10\^9cfu) for 60days
probiotic k56 capsule, 2capsules/d (10\^10cfu) for 60days
probiotic k56 capsule, 4capsules/d (10\^11cfu) for 60days
Eligibility Criteria
You may qualify if:
- BMI\>=30kg/m2,or percent of body fat(PBF) \>=25% for male, \>=30 for female.
- Age: 18 - 60 years old adults
You may not qualify if:
- patients with severe chronic diseases (coronary heart disease, diabetes, hypertension, immune deficiency, mental disorders, tumors, liver and kidney dysfunction, etc.) and complications;irritable bowel syndrome
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- Inner Mongolia Yili Industrial Group Co., Ltdcollaborator
Study Sites (1)
Hua Dong Hospital Affiliated to Fu Dan University
Shanghai, China
Related Publications (1)
Kadeer G, Fu W, He Y, Feng Y, Liu WH, Hung WL, Feng H, Zhao W. Effect of different doses of Lacticaseibacillus paracasei K56 on body fat and metabolic parameters in adult individuals with obesity: a pilot study. Nutr Metab (Lond). 2023 Mar 21;20(1):16. doi: 10.1186/s12986-023-00739-y.
PMID: 36944956DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying Feng, Ph.D
Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 8, 2021
First Posted
July 28, 2021
Study Start
January 10, 2021
Primary Completion
August 30, 2021
Study Completion
December 31, 2021
Last Updated
January 10, 2023
Record last verified: 2021-07