NCT05192811

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 14, 2022

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

December 13, 2021

Last Update Submit

December 30, 2021

Conditions

Obesity

Keywords

obesitylactobacillus paracaseibody fatvisceral fat areagut microbiota

Outcome Measures

Primary Outcomes (2)

  • visceral fat area (cm^2)

    VFA (cm\^2) will be assessed at baseline and after 60days of intervention

    60days

  • percent body fat (%)

    PBF (%) will be assessed at baseline and after 60days of intervention

    60days

Secondary Outcomes (9)

  • body weight

    60days

  • Body Mass Index BMI

    60 days

  • waist circumference (cm)

    Baseline, 60 days

  • hip circumference(cm)

    60 days

  • waist to hip ratio (WHR)

    60 days

  • +4 more secondary outcomes

Study Arms (2)

probiotic K56

EXPERIMENTAL

Probiotic capsule (lactobacillus paracasei K56 10\^9CFU) 1capsule/day , for 60days

Dietary Supplement: Lactobacillus paracasei K56

placebo

PLACEBO COMPARATOR

placebo capsule(maltodextrin, 1capsule/day, 60days

Dietary Supplement: placebo

Interventions

Lactobacillus paracasei K56DIETARY_SUPPLEMENT

probiotic K56 capsule, 1capsule/day (10\^9cfu) ,for 60days

probiotic K56
placeboDIETARY_SUPPLEMENT

placebo capsule(maltodextrin) , 1capsule/day ,for 60days

placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hua Dong Hospital Affiliated to Fu Dan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ying Feng, Ph.D

    Hua Dong Hospita Affiliated to Fu Dan University, Shanghai,China

    STUDY DIRECTOR

Central Study Contacts

Ying Feng, Ph.D

CONTACT

+86 18121221972yingfenghd@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 14, 2022

Study Start

November 18, 2021

Primary Completion

March 30, 2022

Study Completion

December 1, 2022

Last Updated

January 14, 2022

Record last verified: 2021-11

Locations

CN(1)