ObesityNCT02733484
Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity
A study testing Probiotics in people with Obesity, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the probiotics will be effective in the treatment of obesity Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15-60 years
- BMI≥28.0kg/m2
- Agree to cooperate in the trial
- Provision of written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
Cuiling Zhu, MD, 18817951953, 1263856671@qq.com
Renyuan Gao, MD, renyuangao@126.com
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- Probiotics, Placebo
- Keywords
- Obesity,Probiotics,Treatment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
PlaceboDietary supplement
the patients in this arm will receive placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | the patients in this arm will receive placebo with similar appearance of probiotics. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
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
Measured: 3 months
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
Measured: 1 month
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
Measured: 3 months
Secondary outcomes (38)
change from baseline in gut microbiota at 1 month
study the microbiota change of stool samples at 1 month in comparison with the baseline
Measured: 1 month
change from baseline in gut microbiota at 3 months
study the microbiota change of stool samples at 3 months in comparison with the baseline
Measured: 3 months
change from baseline in triglyceride at 1 month
Measured: 1 month
change from baseline in triglyceride at 3 months
Measured: 3 months
change from baseline in cholesterol at 1 month
Measured: 1 month
change from baseline in cholesterol at 3 months
Measured: 3 months
change from baseline in high-density lipoprotein at 1 month
Measured: 1 month
change from baseline in high-density lipoprotein at 3 months
Measured: 3 months
change from baseline in low-density lipoprotein at 1 month
Measured: 1 month
change from baseline in low-density lipoprotein at 3 months
Measured: 3 months
change from baseline in glutamic oxalacetic transaminase at 1 month
Measured: 1 month
change from baseline in glutamic oxalacetic transaminase at 3 months
Measured: 3 months
change from baseline in alkaline transaminase at 1 month
Measured: 1 month
change from baseline in alkaline transaminase at 3 months
Measured: 3 months
change from baseline in alkaline phosphatase at 1 month
Measured: 1 month
change from baseline in alkaline phosphatase at 3 months
Measured: 3 months
change from baseline in superoxide dismutase at 1 month
Measured: 1 month
change from baseline in superoxide dismutase at 3 months
Measured: 3 months
change from baseline in C-reactive protein at 1 month
Measured: 1 month
change from baseline in C-reactive protein at 3 months
Measured: 3 months
change from baseline in uric acid at 1 month
Measured: 1 month
change from baseline in uric acid at 3 months
Measured: 3 months
change from baseline in tumor necrosis factor-a at 1 month
Measured: 1 month
change from baseline in tumor necrosis factor-a at 3 months
Measured: 3 months
change from baseline in interleukin-6 at 1 month
Measured: 1 month
change from baseline in interleukin-6 at 3 months
Measured: 3 months
change from baseline in interleukin-8 at 1 month
Measured: 1 month
change from baseline in interleukin-8 at 3 months
Measured: 3 months
change from baseline in fasting insulin at 1 month
Measured: 1 month
change from baseline in fasting insulin at 3 months
Measured: 3 months
change from baseline in c peptide at 1 month
Measured: 1 month
change from baseline in c peptide at 3 months
Measured: 3 months
change from baseline in visceral fat fraction at 1 month
Measured: 1 month
change from baseline in visceral fat fraction at 3 months
Measured: 3 months
change from baseline in body age at 1 month
Measured: 1 month
change from baseline in body age at 3 months
Measured: 3 months
change from baseline in percentage of body fat at 1 month
Measured: 1 month
change from baseline in percentage of body fat at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
- Investigators
- Huanlong Qin, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733484
- Sponsor's protocol ID
- PTD02
- Status last verified
- Mar 2017
- First submitted
- 5 Apr 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Obesity: a Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02733484
- Acronym / sponsor ID
- PTD02
- Conditions
- Obesity
- Keywords
- Obesity,Probiotics,Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probioticsthe patients in this arm will receive probiotics with a dose for 2g/d for 3 months. |
| Placebo | Placebo comparator | Dietary Supplement: Placebothe patients in this arm will receive placebo with similar appearance of probiotics. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 15-60 years
- BMI≥28.0kg/m2
- Agree to cooperate in the trial
- Provision of written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probioticsthe patients in this arm will receive probiotics with a dose for 2g/d for 3 months. | Dietary supplement | Probiotics |
| Placebothe patients in this arm will receive placebo intervention | Dietary supplement | Placebo |
Primary outcome
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
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
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
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
38 secondary outcomes
change from baseline in gut microbiota at 1 month
Time frame: 1 month
change from baseline in gut microbiota at 3 months
Time frame: 3 months
change from baseline in triglyceride at 1 month
Time frame: 1 month
change from baseline in triglyceride at 3 months
Time frame: 3 months
change from baseline in cholesterol at 1 month
Time frame: 1 month
change from baseline in cholesterol at 3 months
Time frame: 3 months
change from baseline in high-density lipoprotein at 1 month
Time frame: 1 month
change from baseline in high-density lipoprotein at 3 months
Time frame: 3 months
change from baseline in low-density lipoprotein at 1 month
Time frame: 1 month
change from baseline in low-density lipoprotein at 3 months
Time frame: 3 months
change from baseline in glutamic oxalacetic transaminase at 1 month
Time frame: 1 month
change from baseline in glutamic oxalacetic transaminase at 3 months
Time frame: 3 months
change from baseline in alkaline transaminase at 1 month
Time frame: 1 month
change from baseline in alkaline transaminase at 3 months
Time frame: 3 months
change from baseline in alkaline phosphatase at 1 month
Time frame: 1 month
change from baseline in alkaline phosphatase at 3 months
Time frame: 3 months
change from baseline in superoxide dismutase at 1 month
Time frame: 1 month
change from baseline in superoxide dismutase at 3 months
Time frame: 3 months
change from baseline in C-reactive protein at 1 month
Time frame: 1 month
change from baseline in C-reactive protein at 3 months
Time frame: 3 months
change from baseline in uric acid at 1 month
Time frame: 1 month
change from baseline in uric acid at 3 months
Time frame: 3 months
change from baseline in tumor necrosis factor-a at 1 month
Time frame: 1 month
change from baseline in tumor necrosis factor-a at 3 months
Time frame: 3 months
change from baseline in interleukin-6 at 1 month
Time frame: 1 month
change from baseline in interleukin-6 at 3 months
Time frame: 3 months
change from baseline in interleukin-8 at 1 month
Time frame: 1 month
change from baseline in interleukin-8 at 3 months
Time frame: 3 months
change from baseline in fasting insulin at 1 month
Time frame: 1 month
change from baseline in fasting insulin at 3 months
Time frame: 3 months
change from baseline in c peptide at 1 month
Time frame: 1 month
change from baseline in c peptide at 3 months
Time frame: 3 months
change from baseline in visceral fat fraction at 1 month
Time frame: 1 month
change from baseline in visceral fat fraction at 3 months
Time frame: 3 months
change from baseline in body age at 1 month
Time frame: 1 month
change from baseline in body age at 3 months
Time frame: 3 months
change from baseline in percentage of body fat at 1 month
Time frame: 1 month
change from baseline in percentage of body fat at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huanlong Qin principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Obesity, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cuiling Zhu, MD (18817951953, 1263856671@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in fasting blood-glucose at 1 month (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.