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

Primary Purpose

Pre-diabetic

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Yeast Beta-glucan

Placebo

About this trial

This is an interventional prevention trial for Pre-diabetic focused on measuring Yeast Beta-glucan, Immune Function, Prediabetes, Gut Microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Changes in inflammatory factors

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

FPG(fasten plasma glucose), OGTT（oral glucose tolerance test）

Changes in gut microbiota

High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform.

Changes in RTI(respiratory tract infection)

Observe the clinical symptoms of respiratory infections in two groups of patients

Changes in islet function

C-peptide level

Secondary Outcome Measures

Changes in SCFA (short chain fatty acids)

Using GC-MS to detect fecal and plasma SCFA

Changes in blood lipids profile

Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides.

Changes in hepatorenal function

Using automatic biochemical analyzer to detect creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase and so on

Full Information

NCT ID

NCT03495362

First Posted

March 22, 2018

Last Updated

April 4, 2018

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT03495362

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 13, 2018 (Actual)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetic

Keywords

Yeast Beta-glucan, Immune Function, Prediabetes, Gut Microbiota

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes 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).

Allocation

Randomized

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Yeast Beta-glucan

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs)

Description

Time Frame

At 0 week, 6th week, 12th week in the intervention period.

Title

Changes in inflammatory factors

Description

Using ELISA to detect the expression level of TNF-α, IL-6, IL-1β, IL-12, IL-10, TGF-β

Time Frame

At 0 week, 6th week, 12th week in the intervention period.

Title

Changes in blood glucose level

Description

FPG(fasten plasma glucose), OGTT（oral glucose tolerance test）

Time Frame

At 0 week, 12th week in the intervention period.

Title

Changes in gut microbiota

Description

High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform.

Time Frame

At 0 week, 6th week, 12th week in the intervention period.

Title

Changes in RTI(respiratory tract infection)

Description

Observe the clinical symptoms of respiratory infections in two groups of patients

Time Frame

Every week across the intervention peroid，an average of 3 months.

Title

Changes in islet function

Description

C-peptide level

Time Frame

At 0 week, 12th week in the intervention period.

Secondary Outcome Measure Information:

Title

Changes in SCFA (short chain fatty acids)

Description

Using GC-MS to detect fecal and plasma SCFA

Time Frame

At 0 week, 6th week, 12th week in the intervention period.

Title

Changes in blood lipids profile

Description

Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides.

Time Frame

At 0 week, 12th week in the intervention period.

Title

Changes in hepatorenal function

Description

Using automatic biochemical analyzer to detect creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase and so on

Time Frame

At 0 week, 12th week in the intervention period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liegang Liu, MD, PhD

Phone

+86-27-83650522

liegangliu@gmail.com

Facility Information:

Facility Name

Huazhong University of Science and Technology

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Contact: