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

Tongji University

Status: Unknown

Conditions: Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT02733484

PTD02

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo