Hyperglycemia, Insulin Sensitivity
Conditions
Keywords
Hyperglycemia, Prebiotics
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.
Interventions
DIETARY_SUPPLEMENTHighland barley β-glucan dietary supplement
100 mL oral liquid mainly containing highland barley β-glucan once daily for 8 weeks
OTHERPlacebo controls
Placebo with a similar appearance and taste to highland barley β-glucan supplement
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
Intervention model description
placebo-controlled, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 30-65 years old 2. 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 3. BMI≥18 kg/ m2
Exclusion criteria
1. Receiving or have been treated with hypoglycemic drugs or insulin. 2. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke. 3. 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). 4. Autoimmune diseases or thyroid diseases. 5. Women who are pregnant, nursing, or prepare to give birth during the trail. 6. Malignant disease, infectious disease, inflammatory disease and advanced liver disease. 7. Mental or intellectual abnormalities, unable to sign informed consent. 8. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit. 9. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail. 10. Major operations were performed within six months of screening visit, or will be made during the trial. 11. Alcohol abuse (alcohol intake\>60g/d for male and alcohol intake\>40g/d for female)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fasting venous plasma glucose | baseline and after 8-week intervention | changes of fasting venous plasma glucose levels |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gut microbiota | baseline and after 8-week intervention | changes of gut microbiota |
| flow-mediated dilation | baseline and after 8-week intervention | changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory |
| microbial metabolites | baseline and after 8-week intervention | changes of microbial metabolites by untargeted metabolomics |
| Matsuda index | baseline and after 8-week intervention | changes of Matsuda index based on OGTT |
Countries
China
Outcome results
None listed