The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients: a Randomized Double-blind Trial

Conditions
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Pre-diabetic

Intervention / Treatment
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* Dietary Supplement: Yeast Beta-glucan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18-65 years Meet the pre-diabetes diagnostic criteria recommended by World Health Organization (WHO) in 1999 Exclusion Criteria: Allergic to test substances Known severe heart, liver, kidney, autoimmune diseases, psychosis, nervous system, hematopoietic system, endocrine and other systemic diseases Known acute disease, common cold, metabolic diseases, chronic inflammation, infectious diseases, and heavy physical labor recently Usage of antihyperlipidemia or antihypertension, and other drugs may influence the interventional effect last two weeks Unable to cooperate with researchers or maintain ordinary dietary habit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Dietary Supplement: Yeast Beta-glucan<br>* Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.<br>|
| Placebo Comparator: Placebo group<br>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. | Other: Placebo<br>* Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yeast Beta-glucan, Immune Function, Prediabetes, Gut Microbiota