Effect of Prebiotics on Blood Glucose Management
- Conditions
- HyperglycemiaInsulin Sensitivity
- Interventions
- Dietary Supplement: Highland barley β-glucan dietary supplementOther: Placebo controls
- Registration Number
- NCT04636489
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Highland barley β-glucan group Highland barley β-glucan dietary supplement Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 8 weeks followed by comprehensive physical and clinical examinations. Placebo group Placebo controls Participants will be given oral liquids mainly containing Corn starch once daily for 8 weeks followed by comprehensive physical and clinical examinations.
- Primary Outcome Measures
Name Time Method plasma glucose 2 h after an oral glucose load baseline and after 8-week intervention changes of plasma glucose levels 2 h after an oral glucose load
glycosylated hemoglobin baseline and after 8-week intervention changes of glycosylated hemoglobin levels
fasting venous plasma glucose baseline and after 8-week intervention changes of fasting venous plasma glucose levels
- Secondary Outcome Measures
Name Time Method gut microbiota baseline and after 8-week intervention changes of gut microbiota
Matsuda index baseline and after 8-week intervention changes of Matsuda index based on OGTT
microbial metabolites baseline and after 8-week intervention changes of microbial metabolites by untargeted metabolomics
flow-mediated dilation baseline and after 8-week intervention changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory
Trial Locations
- Locations (1)
Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China