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There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.However,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. This is a randomized double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of prediabetic patients. Firstly, the investigators will go into the efficacy of yeast beta-glucan on improving the clinical symptoms of prediabetics. Secondly, the investigators will study the mechanism of yeast beta-glucan on enhancing the immune function and improving the inflammatory response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Ingredients: yeast beta-glucan, and capsule shell Capsule, per capsule with 500mg insoluble beta-glucan, twice a day, 1 capsule each time. The intervention period is about 3 months. |
|
| Placebo group | Placebo Comparator | Ingredients: starch, and capsule shell Capsule, per capsule with 500mg starch, twice a day, 1 capsule each time. The intervention period is about 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yeast Beta-glucan | Dietary Supplement | Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs) | Extract and isolate PBMCs from participants. Using flow cytometry to detect the differentiation rates of some PBMCs（Peripheral Blood Mononuclear Cells）inculding T, B, NK, CD4+, CD8+, CD19+, CD138+, CD3+ and CD45+ cells | At 0 week, 6th week, 12th week in the intervention period. |
| Changes in inflammatory factors | Using ELISA to detect the expression level of TNF-α, IL-6, IL-1β, IL-12, IL-10, TGF-β | At 0 week, 6th week, 12th week in the intervention period. |
| Changes in blood glucose level | FPG(fasten plasma glucose), OGTT（oral glucose tolerance test） | At 0 week, 12th week in the intervention period. |
| Changes in gut microbiota | High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform. | At 0 week, 6th week, 12th week in the intervention period. |
| Changes in RTI(respiratory tract infection) | Observe the clinical symptoms of respiratory infections in two groups of patients | Every week across the intervention peroid，an average of 3 months. |
| Changes in islet function | C-peptide level | At 0 week, 12th week in the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in SCFA (short chain fatty acids) | Using GC-MS to detect fecal and plasma SCFA | At 0 week, 6th week, 12th week in the intervention period. |
| Changes in blood lipids profile | Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liegang Liu, MD, PhD | Contact | +86-27-83650522 | liegangliu@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The all details of groups assignment are arranged and controlled by the research designers. The color, shape, and external packaging of the yeast beta-glucan and placebo are consistent. Each bottle of capsules will be marked with the name (or identify number) of the participants by research designers. Thus, the grouping of participants is blind to the rest of the researchers (like outcomes assessors).
| Placebo | Other | Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. |
|
| At 0 week, 12th week in the intervention period. |
| Changes in hepatorenal function | Using automatic biochemical analyzer to detect creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase and so on | At 0 week, 12th week in the intervention period. |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |