Clinical trial NCT04636489: Effect of Prebiotics on Blood Glucose Management
Official title: An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Glucose Metabolism and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia
Insulin Sensitivity
Keywords: Hyperglycemia
Prebiotics
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled, randomized clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: fasting venous plasma glucose
timeFrame: baseline and after 8-week intervention
measure: plasma glucose 2 h after an oral glucose load
timeFrame: baseline and after 8-week intervention
measure: glycosylated hemoglobin
timeFrame: baseline and after 8-week intervention
Secondary outcomes:
measure: gut microbiota
timeFrame: baseline and after 8-week intervention
measure: microbial metabolites
timeFrame: baseline and after 8-week intervention
measure: Matsuda index
timeFrame: baseline and after 8-week intervention
measure: flow-mediated dilation
timeFrame: baseline and after 8-week intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Min Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: