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

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ClinicalTrials.gov Identifier: NCT03495362
Recruitment Status : Unknown
Verified April 2018 by Liegang Liu, Huazhong University of Science and Technology.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date April 12, 2018
Actual Study Start Date  ICMJE March 13, 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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
  • 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
  • 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)
  • 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.
  • 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
  • Changes in islet function [ Time Frame: At 0 week, 12th week in the intervention period. ]
    C-peptide level
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients
Official Title  ICMJE The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients: a Randomized Double-blind Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Pre-diabetic
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Intervention: Dietary Supplement: Yeast Beta-glucan
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495362
Other Study ID Numbers  ICMJE CHW20180201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Liegang Liu, Huazhong University of Science and Technology
Study Sponsor  ICMJE Huazhong University of Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Huazhong University of Science and Technology
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP