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

March 9, 2017 updated by: Huanlong Qin, Shanghai 10th People's Hospital

Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity: a Randomized, Double-blind Controlled Trial

The purpose of this study is to determine whether the probiotics will be effective in the treatment of obesity

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Shanghai 10th People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shen Qu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotics
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
Dietary supplement: Probiotics
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
Placebo Comparator: Placebo
the patients in this arm will receive placebo with similar appearance of probiotics.
Dietary supplement: Placebo
the patients in this arm will receive placebo intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change from baseline in fasting blood-glucose at 1 month
Time Frame: 1 month
change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline
1 month
change from baseline in fasting blood-glucose at 3 months
Time Frame: 3 months
change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline
3 months
change from baseline in glycosylated hemoglobin change at 1 month
Time Frame: 1 month
change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline
1 month
change from baseline in glycosylated hemoglobin change at 3 months
Time Frame: 3 months
change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change from baseline in gut microbiota at 1 month
Time Frame: 1 month
study the microbiota change of stool samples at 1 month in comparison with the baseline
1 month
change from baseline in gut microbiota at 3 months
Time Frame: 3 months
study the microbiota change of stool samples at 3 months in comparison with the baseline
3 months
change from baseline in triglyceride at 1 month
Time Frame: 1 month
1 month
change from baseline in triglyceride at 3 months
Time Frame: 3 months
3 months
change from baseline in cholesterol at 1 month
Time Frame: 1 month
1 month
change from baseline in cholesterol at 3 months
Time Frame: 3 months
3 months
change from baseline in high-density lipoprotein at 1 month
Time Frame: 1 month
1 month
change from baseline in high-density lipoprotein at 3 months
Time Frame: 3 months
3 months
change from baseline in low-density lipoprotein at 1 month
Time Frame: 1 month
1 month
change from baseline in low-density lipoprotein at 3 months
Time Frame: 3 months
3 months
change from baseline in glutamic oxalacetic transaminase at 1 month
Time Frame: 1 month
1 month
change from baseline in glutamic oxalacetic transaminase at 3 months
Time Frame: 3 months
3 months
change from baseline in alkaline transaminase at 1 month
Time Frame: 1 month
1 month
change from baseline in alkaline transaminase at 3 months
Time Frame: 3 months
3 months
change from baseline in alkaline phosphatase at 1 month
Time Frame: 1 month
1 month
change from baseline in alkaline phosphatase at 3 months
Time Frame: 3 months
3 months
change from baseline in superoxide dismutase at 1 month
Time Frame: 1 month
1 month
change from baseline in superoxide dismutase at 3 months
Time Frame: 3 months
3 months
change from baseline in C-reactive protein at 1 month
Time Frame: 1 month
1 month
change from baseline in C-reactive protein at 3 months
Time Frame: 3 months
3 months
change from baseline in uric acid at 1 month
Time Frame: 1 month
1 month
change from baseline in uric acid at 3 months
Time Frame: 3 months
3 months
change from baseline in tumor necrosis factor-a at 1 month
Time Frame: 1 month
1 month
change from baseline in tumor necrosis factor-a at 3 months
Time Frame: 3 months
3 months
change from baseline in interleukin-6 at 1 month
Time Frame: 1 month
1 month
change from baseline in interleukin-6 at 3 months
Time Frame: 3 months
3 months
change from baseline in interleukin-8 at 1 month
Time Frame: 1 month
1 month
change from baseline in interleukin-8 at 3 months
Time Frame: 3 months
3 months
change from baseline in fasting insulin at 1 month
Time Frame: 1 month
1 month
change from baseline in fasting insulin at 3 months
Time Frame: 3 months
3 months
change from baseline in c peptide at 1 month
Time Frame: 1 month
1 month
change from baseline in c peptide at 3 months
Time Frame: 3 months
3 months
change from baseline in visceral fat fraction at 1 month
Time Frame: 1 month
1 month
change from baseline in visceral fat fraction at 3 months
Time Frame: 3 months
3 months
change from baseline in body age at 1 month
Time Frame: 1 month
1 month
change from baseline in body age at 3 months
Time Frame: 3 months
3 months
change from baseline in percentage of body fat at 1 month
Time Frame: 1 month
1 month
change from baseline in percentage of body fat at 3 months
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 10th People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Huanlong Qin, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PTD02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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