Effect of Prebiotics on Blood Glucose Management

Sun Yat-sen University

Status: Active, not recruiting

Conditions: Hyperglycemia; Insulin Sensitivity

Treatments: Dietary Supplement: Highland barley β-glucan dietary supplement; Other: Placebo controls

Study type: Interventional

Funder types: Other

Identifiers

NCT04636489

2020HBβG-D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

90 participants in 2 patient groups, including a placebo group

Highland barley β-glucan group

Experimental group

Description:

Participants will be given oral liquids mainly containing highland barley β-glucan once daily for 8 weeks followed by comprehensive physical and clinical examinations.

Treatment:

Dietary Supplement: Highland barley β-glucan dietary supplement

Placebo group

Placebo Comparator group

Description:

Participants will be given oral liquids mainly containing Corn starch once daily for 8 weeks followed by comprehensive physical and clinical examinations.

Treatment:

Other: Placebo controls