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

Not Applicable

• Conditions: Pre-diabetic

• Registration Number: NCT03495362
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-13
• Study First Submitted: 2018-03-22
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-04
• Last Update Submitted: 2018-04-04
• Study First Posted: 2018-04-12
• Last Update Posted: 2018-04-12
• Primary Completion: 2018-11
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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 islet function	At 0 week, 12th week in the intervention period.	C-peptide level

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China