Effect of Prebiotics on Blood Glucose Management

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04636489
• Other study ID #: 2020HBßG-D
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperglycemia
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity

Intervention

Dietary Supplement:
• Highland barley ß-glucan dietary supplement
100 mL oral liquid mainly containing highland barley ß-glucan once daily for 8 weeks

Other:
• Placebo controls
Placebo with a similar appearance and taste to highland barley ß-glucan supplement

Locations

Country	Name	City	State
China	Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting venous plasma glucose	changes of fasting venous plasma glucose levels	baseline and after 8-week intervention
Primary	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
Primary	glycosylated hemoglobin	changes of glycosylated hemoglobin levels	baseline and after 8-week intervention
Secondary	gut microbiota	changes of gut microbiota	baseline and after 8-week intervention
Secondary	microbial metabolites	changes of microbial metabolites by untargeted metabolomics	baseline and after 8-week intervention
Secondary	Matsuda index	changes of Matsuda index based on OGTT	baseline and after 8-week intervention
Secondary	flow-mediated dilation	changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory	baseline and after 8-week intervention