Effect of Prebiotics on Blood Glucose Management

Study Overview
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Brief Summary
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This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood glucose, gut microbiota and cardiovascular risk fators in subjects with hyperglycemia.

Detailed Description
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Highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits. However, its protective role in subjects with hyperglycemia are remain unclear. This study aims to examine the effect of 8-week prebiotics supplementation on glucose management in subjects with hyperglycemia. By understanding the mechanism by which prebiotics exert the beneficial effects, we can better control the rising prevalence of hyperglycemia, which is a major risk factor for cardiovascular diseases.

Official Title
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An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Glucose Metabolism and Insulin Sensitivity

Conditions
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Hyperglycemia, Insulin Sensitivity

Intervention / Treatment
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* Dietary Supplement: Highland barley β-glucan dietary supplement
* Other: Placebo controls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 30-65 years old Fasting venous plasma glucose ≥5.6mmol/L OR plasma glucose 2 h after an oral glucose load ≥7.8mmol/L OR glycosylated hemoglobin ≥5.7% OR newly diagnosed diabetes without hypoglycemic drugs using BMI≥18 kg/ m2 Exclusion Criteria: Receiving or have been treated with hypoglycemic drugs or insulin. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke. Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR<30ml/min/1.73m2). Autoimmune diseases or thyroid diseases. Women who are pregnant, nursing, or prepare to give birth during the trail. Malignant disease, infectious disease, inflammatory disease and advanced liver disease. Mental or intellectual abnormalities, unable to sign informed consent. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail. Major operations were performed within six months of screening visit, or will be made during the trial. Alcohol abuse (alcohol intake>60g/d for male and alcohol intake>40g/d for female)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo-controlled, randomized clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Highland barley β-glucan group<br>Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 8 weeks followed by comprehensive physical and clinical examinations. | Dietary Supplement: Highland barley β-glucan dietary supplement<br>* 100 mL oral liquid mainly containing highland barley β-glucan once daily for 8 weeks<br>|
| Placebo Comparator: Placebo group<br>Participants will be given oral liquids mainly containing Corn starch once daily for 8 weeks followed by comprehensive physical and clinical examinations. | Other: Placebo controls<br>* Placebo with a similar appearance and taste to highland barley β-glucan supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting venous plasma glucose | changes of fasting venous plasma glucose levels | baseline and after 8-week intervention | 
| plasma glucose 2 h after an oral glucose load | changes of plasma glucose levels 2 h after an oral glucose load | baseline and after 8-week intervention | 
| glycosylated hemoglobin | changes of glycosylated hemoglobin levels | baseline and after 8-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gut microbiota | changes of gut microbiota | baseline and after 8-week intervention | 
| microbial metabolites | changes of microbial metabolites by untargeted metabolomics | baseline and after 8-week intervention | 
| Matsuda index | changes of Matsuda index based on OGTT | baseline and after 8-week intervention | 
| flow-mediated dilation | changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory | baseline and after 8-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperglycemia, Prebiotics