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Trial record 10 of 228 for:    yeast

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

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ClinicalTrials.gov Identifier: NCT03495362
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Liegang Liu, 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.

Condition or disease Intervention/treatment Phase
Pre-diabetic Dietary Supplement: Yeast Beta-glucan Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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).
Primary Purpose: Prevention
Official Title: The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients: a Randomized Double-blind Trial
Actual Study Start Date : March 13, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




Primary Outcome Measures :
  1. Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs) [ Time Frame: 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

  2. Changes in inflammatory factors [ Time Frame: 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

  3. Changes in blood glucose level [ Time Frame: At 0 week, 12th week in the intervention period. ]
    FPG(fasten plasma glucose), OGTT(oral glucose tolerance test)

  4. Changes in gut microbiota [ Time Frame: At 0 week, 6th week, 12th week in the intervention period. ]
    High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform.

  5. Changes in RTI(respiratory tract infection) [ Time Frame: Every week across the intervention peroid,an average of 3 months. ]
    Observe the clinical symptoms of respiratory infections in two groups of patients

  6. Changes in islet function [ Time Frame: At 0 week, 12th week in the intervention period. ]
    C-peptide level


Secondary Outcome Measures :
  1. Changes in SCFA (short chain fatty acids) [ Time Frame: At 0 week, 6th week, 12th week in the intervention period. ]
    Using GC-MS to detect fecal and plasma SCFA

  2. Changes in blood lipids profile [ Time Frame: At 0 week, 12th week in the intervention period. ]
    Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides.

  3. Changes in hepatorenal function [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495362


Contacts
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Contact: Liegang Liu, MD, PhD +86-27-83650522 liegangliu@gmail.com

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

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Responsible Party: Liegang Liu, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03495362     History of Changes
Other Study ID Numbers: CHW20180201
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liegang Liu, Huazhong University of Science and Technology:
Yeast Beta-glucan
Immune Function
Prediabetes
Gut Microbiota
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases