Clinical trial NCT03495362: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-diabetic
Keywords: Yeast Beta-glucan
Immune Function
Prediabetes
Gut Microbiota
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs)
timeFrame: At 0 week, 6th week, 12th week in the intervention period.
measure: Changes in inflammatory factors
timeFrame: At 0 week, 6th week, 12th week in the intervention period.
measure: Changes in blood glucose level
timeFrame: At 0 week, 12th week in the intervention period.
measure: Changes in gut microbiota
timeFrame: At 0 week, 6th week, 12th week in the intervention period.
measure: Changes in RTI(respiratory tract infection)
timeFrame: Every week across the intervention peroid，an average of 3 months.
measure: Changes in islet function
timeFrame: At 0 week, 12th week in the intervention period.
Secondary outcomes:
measure: Changes in SCFA (short chain fatty acids)
timeFrame: At 0 week, 6th week, 12th week in the intervention period.
measure: Changes in blood lipids profile
timeFrame: At 0 week, 12th week in the intervention period.
measure: Changes in hepatorenal function
timeFrame: At 0 week, 12th week in the intervention period.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
References: