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

Pre-diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03495362
• Other study ID #: CHW20180201
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2018
• Last updated: April 4, 2018
• Start date: March 13, 2018
• Est. completion date: March 2019

Study information

• Verified date: April 2018
• Source: Huazhong University of Science and Technology
• Contact: Liegang Liu, MD, PhD
• Phone: +86-27-83650522
• Email: liegangliu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: March 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-diabetic
• Prediabetic State

Intervention

Dietary Supplement:
• Yeast Beta-glucan
Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Other:
• Placebo
Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

Locations

Country	Name	City	State
China	Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Changes in inflammatory factors	Using ELISA to detect the expression level of TNF-a, IL-6, IL-1ß, IL-12, IL-10, TGF-ß	At 0 week, 6th week, 12th week in the intervention period.
Primary	Changes in blood glucose level	FPG(fasten plasma glucose), OGTT(oral glucose tolerance test)	At 0 week, 12th week in the intervention period.
Primary	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.
Primary	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.
Primary	Changes in islet function	C-peptide level	At 0 week, 12th week in the intervention period.
Secondary	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.
Secondary	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.
Secondary	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.