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

NCT03495362 | Unknown

• 1 other identifier: CHW20180201
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetic

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Changes in SCFA (short chain fatty acids)

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

• Changes in blood lipids profile

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

• Changes in hepatorenal function

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Yeast Beta-glucan DIETARY_SUPPLEMENT

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

Intervention group

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18-65 years
• Meet the pre-diabetes diagnostic criteria recommended by World Health Organization (WHO) in 1999

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Liegang Liu, MD, PhD

CONTACT

+86-27-83650522; liegangliu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 12, 2018
• Study Start: March 13, 2018
• Primary Completion: November 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

CN (1)