Effect of Prebiotics on Blood Glucose Management

NCT04636489 | Unknown DMC

• 1 other identifier: 2020HBβG-D
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Insulin Sensitivity

Keywords

Hyperglycemia; Prebiotics

Outcome Measures

Primary Outcomes (3)

• fasting venous plasma glucose

  changes of fasting venous plasma glucose levels

  baseline and after 8-week intervention

• 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

• glycosylated hemoglobin

  changes of glycosylated hemoglobin levels

  baseline and after 8-week intervention

Secondary Outcomes (4)

• gut microbiota

  baseline and after 8-week intervention

• microbial metabolites

  baseline and after 8-week intervention

• Matsuda index

  baseline and after 8-week intervention

• flow-mediated dilation

  baseline and after 8-week intervention

Study Arms (2)

Highland barley β-glucan group

EXPERIMENTAL

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

Dietary Supplement: Highland barley β-glucan dietary supplement

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo controls

Interventions

Highland barley β-glucan dietary supplement DIETARY_SUPPLEMENT

100 mL oral liquid mainly containing highland barley β-glucan once daily for 8 weeks

Highland barley β-glucan group

Placebo controls OTHER

Placebo with a similar appearance and taste to highland barley β-glucan supplement

Placebo group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• Min Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: placebo-controlled, randomized clinical trial

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 19, 2020
• Study Start: November 30, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)