Pre-diabetic
Conditions
Keywords
Yeast Beta-glucan, Immune Function, Prediabetes, Gut Microbiota
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTYeast Beta-glucan
Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
OTHERPlacebo
Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in islet function | At 0 week, 12th week in the intervention period. | C-peptide level |
| Changes in blood glucose level | At 0 week, 12th week in the intervention period. | FPG(fasten plasma glucose), OGTT（oral glucose tolerance test） |
| Changes in gut microbiota | At 0 week, 6th week, 12th week in the intervention period. | High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform. |
| Changes in RTI(respiratory tract infection) | Every week across the intervention peroid，an average of 3 months. | Observe the clinical symptoms of respiratory infections in two groups of patients |
| Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs) | At 0 week, 6th week, 12th week in the intervention period. | 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 |
| Changes in inflammatory factors | At 0 week, 6th week, 12th week in the intervention period. | Using ELISA to detect the expression level of TNF-α, IL-6, IL-1β, IL-12, IL-10, TGF-β |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in blood lipids profile | At 0 week, 12th week in the intervention period. | Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides. |
| Changes in hepatorenal function | At 0 week, 12th week in the intervention period. | Using automatic biochemical analyzer to detect creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase and so on |
| Changes in SCFA (short chain fatty acids) | At 0 week, 6th week, 12th week in the intervention period. | Using GC-MS to detect fecal and plasma SCFA |
Countries
China
Contacts
Primary ContactLiegang Liu, MD, PhD
Outcome results
None listed