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Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity,Probiotics,Treatment

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 15-60 years
  2. BMI≥28.0kg/m2
  3. Agree to cooperate in the trial
  4. Provision of written informed consent

Exclusion Criteria:

  1. With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance
  2. Diabetes
  3. Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones
  4. Use any probiotics in the last 3 months
  5. Allergic constitution
  6. Participating in any other clinical trials
  7. Was not able to insist until the end
  8. Pregnant and lactating women

Sites / Locations

  • Shanghai 10th People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics

Placebo

Arm Description

the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.

the patients in this arm will receive placebo with similar appearance of probiotics.

Outcomes

Primary Outcome Measures

change from baseline in fasting blood-glucose at 1 month
change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline
change from baseline in fasting blood-glucose at 3 months
change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline
change from baseline in glycosylated hemoglobin change at 1 month
change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline
change from baseline in glycosylated hemoglobin change at 3 months
change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline

Secondary Outcome Measures

change from baseline in gut microbiota at 1 month
study the microbiota change of stool samples at 1 month in comparison with the baseline
change from baseline in gut microbiota at 3 months
study the microbiota change of stool samples at 3 months in comparison with the baseline
change from baseline in triglyceride at 1 month
change from baseline in triglyceride at 3 months
change from baseline in cholesterol at 1 month
change from baseline in cholesterol at 3 months
change from baseline in high-density lipoprotein at 1 month
change from baseline in high-density lipoprotein at 3 months
change from baseline in low-density lipoprotein at 1 month
change from baseline in low-density lipoprotein at 3 months
change from baseline in glutamic oxalacetic transaminase at 1 month
change from baseline in glutamic oxalacetic transaminase at 3 months
change from baseline in alkaline transaminase at 1 month
change from baseline in alkaline transaminase at 3 months
change from baseline in alkaline phosphatase at 1 month
change from baseline in alkaline phosphatase at 3 months
change from baseline in superoxide dismutase at 1 month
change from baseline in superoxide dismutase at 3 months
change from baseline in C-reactive protein at 1 month
change from baseline in C-reactive protein at 3 months
change from baseline in uric acid at 1 month
change from baseline in uric acid at 3 months
change from baseline in tumor necrosis factor-a at 1 month
change from baseline in tumor necrosis factor-a at 3 months
change from baseline in interleukin-6 at 1 month
change from baseline in interleukin-6 at 3 months
change from baseline in interleukin-8 at 1 month
change from baseline in interleukin-8 at 3 months
change from baseline in fasting insulin at 1 month
change from baseline in fasting insulin at 3 months
change from baseline in c peptide at 1 month
change from baseline in c peptide at 3 months
change from baseline in visceral fat fraction at 1 month
change from baseline in visceral fat fraction at 3 months
change from baseline in body age at 1 month
change from baseline in body age at 3 months
change from baseline in percentage of body fat at 1 month
change from baseline in percentage of body fat at 3 months

Full Information

First Posted
April 5, 2016
Last Updated
March 9, 2017
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02733484
Brief Title
Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity
Official Title
Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity: a Randomized, Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether the probiotics will be effective in the treatment of obesity
Detailed Description
This study aims to evaluate the effect of probiotics on the improvement of glucose and lipid metabolism, as well as the gut microbiota.Baseline, 1 month and 3 months data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical practice for obesity patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity,Probiotics,Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
the patients in this arm will receive placebo with similar appearance of probiotics.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Intervention Description
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
the patients in this arm will receive placebo intervention
Primary Outcome Measure Information:
Title
change from baseline in fasting blood-glucose at 1 month
Description
change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline
Time Frame
1 month
Title
change from baseline in fasting blood-glucose at 3 months
Description
change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline
Time Frame
3 months
Title
change from baseline in glycosylated hemoglobin change at 1 month
Description
change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline
Time Frame
1 month
Title
change from baseline in glycosylated hemoglobin change at 3 months
Description
change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline
Time Frame
3 months
Secondary Outcome Measure Information:
Title
change from baseline in gut microbiota at 1 month
Description
study the microbiota change of stool samples at 1 month in comparison with the baseline
Time Frame
1 month
Title
change from baseline in gut microbiota at 3 months
Description
study the microbiota change of stool samples at 3 months in comparison with the baseline
Time Frame
3 months
Title
change from baseline in triglyceride at 1 month
Time Frame
1 month
Title
change from baseline in triglyceride at 3 months
Time Frame
3 months
Title
change from baseline in cholesterol at 1 month
Time Frame
1 month
Title
change from baseline in cholesterol at 3 months
Time Frame
3 months
Title
change from baseline in high-density lipoprotein at 1 month
Time Frame
1 month
Title
change from baseline in high-density lipoprotein at 3 months
Time Frame
3 months
Title
change from baseline in low-density lipoprotein at 1 month
Time Frame
1 month
Title
change from baseline in low-density lipoprotein at 3 months
Time Frame
3 months
Title
change from baseline in glutamic oxalacetic transaminase at 1 month
Time Frame
1 month
Title
change from baseline in glutamic oxalacetic transaminase at 3 months
Time Frame
3 months
Title
change from baseline in alkaline transaminase at 1 month
Time Frame
1 month
Title
change from baseline in alkaline transaminase at 3 months
Time Frame
3 months
Title
change from baseline in alkaline phosphatase at 1 month
Time Frame
1 month
Title
change from baseline in alkaline phosphatase at 3 months
Time Frame
3 months
Title
change from baseline in superoxide dismutase at 1 month
Time Frame
1 month
Title
change from baseline in superoxide dismutase at 3 months
Time Frame
3 months
Title
change from baseline in C-reactive protein at 1 month
Time Frame
1 month
Title
change from baseline in C-reactive protein at 3 months
Time Frame
3 months
Title
change from baseline in uric acid at 1 month
Time Frame
1 month
Title
change from baseline in uric acid at 3 months
Time Frame
3 months
Title
change from baseline in tumor necrosis factor-a at 1 month
Time Frame
1 month
Title
change from baseline in tumor necrosis factor-a at 3 months
Time Frame
3 months
Title
change from baseline in interleukin-6 at 1 month
Time Frame
1 month
Title
change from baseline in interleukin-6 at 3 months
Time Frame
3 months
Title
change from baseline in interleukin-8 at 1 month
Time Frame
1 month
Title
change from baseline in interleukin-8 at 3 months
Time Frame
3 months
Title
change from baseline in fasting insulin at 1 month
Time Frame
1 month
Title
change from baseline in fasting insulin at 3 months
Time Frame
3 months
Title
change from baseline in c peptide at 1 month
Time Frame
1 month
Title
change from baseline in c peptide at 3 months
Time Frame
3 months
Title
change from baseline in visceral fat fraction at 1 month
Time Frame
1 month
Title
change from baseline in visceral fat fraction at 3 months
Time Frame
3 months
Title
change from baseline in body age at 1 month
Time Frame
1 month
Title
change from baseline in body age at 3 months
Time Frame
3 months
Title
change from baseline in percentage of body fat at 1 month
Time Frame
1 month
Title
change from baseline in percentage of body fat at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 15-60 years BMI≥28.0kg/m2 Agree to cooperate in the trial Provision of written informed consent Exclusion Criteria: With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance Diabetes Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones Use any probiotics in the last 3 months Allergic constitution Participating in any other clinical trials Was not able to insist until the end Pregnant and lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cuiling Zhu, MD
Phone
18817951953
Email
1263856671@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Renyuan Gao, MD
Phone
15601675695
Email
renyuangao@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huanlong Qin
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuiling Zhu, MD
Phone
18817951953
Email
1263856671@qq.com
First Name & Middle Initial & Last Name & Degree
Renyuan Gao, MD
Email
renyuangao@126.com
First Name & Middle Initial & Last Name & Degree
Huanlong Qin, PhD
First Name & Middle Initial & Last Name & Degree
Shen Qu, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity

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