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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pre-diabetic
• Intervention / Treatment: Dietary supplement: Yeast Beta-glucan; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liegang Liu, MD, PhD; Phone Number: +86-27-83650522; Email: liegangliu@gmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Huazhong University of Science and Technology
      • Contact: Liegang Liu, MD, PhD; Phone Number: +86-27-83650522; Email: liegangliu@gmail.com
      • Principal Investigator: Shufang Xu, PhD
      • Principal Investigator: Liangkai Chen, MD
      • Principal Investigator: Xiaoli Hu, MD
      • Principal Investigator: Qiang Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
Placebo Comparator: Placebo group; 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; Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Prediabetes; Gut Microbiota; Immune Function; Yeast Beta-glucan
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: CHW20180201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No