HyperglycemiaNCT04636489
Effect of Prebiotics on Blood Glucose Management
A study testing Highland barley β-glucan dietary supplement in people with Hyperglycemia and Insulin Sensitivity, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Insulin Sensitivity
- What is being tested?
- Highland barley β-glucan dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Glucose Metabolism and Insulin Sensitivity
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.
Read the 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.
- Conditions
- Hyperglycemia, Insulin Sensitivity
- Being tested
- Highland barley β-glucan dietary supplement, Placebo controls
- Keywords
- Hyperglycemia, Prebiotics
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highland barley β-glucan dietary supplementDietary supplement
100 mL oral liquid mainly containing highland barley β-glucan once daily for 8 weeks
Placebo controlsOther
Placebo with a similar appearance and taste to highland barley β-glucan supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting venous plasma glucose
changes of fasting venous plasma glucose levels
Measured: 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
Measured: baseline and after 8-week intervention
glycosylated hemoglobin
changes of glycosylated hemoglobin levels
Measured: baseline and after 8-week intervention
Secondary outcomes (4)
gut microbiota
changes of gut microbiota
Measured: baseline and after 8-week intervention
microbial metabolites
changes of microbial metabolites by untargeted metabolomics
Measured: baseline and after 8-week intervention
Matsuda index
changes of Matsuda index based on OGTT
Measured: baseline and after 8-week intervention
flow-mediated dilation
changes of flow-mediated dilation by VICORDER Complete Vascular Laboratory
Measured: baseline and after 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start30 Nov 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled, randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Xia, Sun Yat-sen University
- Investigators
- Min Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636489
- Sponsor's protocol ID
- 2020HBβG-D
- Status last verified
- May 2022
- First submitted
- 18 Nov 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Glucose Metabolism and Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT04636489
- Acronym / sponsor ID
- 2020HBβG-D
- Conditions
- Hyperglycemia, Insulin Sensitivity
- Keywords
- Hyperglycemia, Prebiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Highland barley β-glucan group | Experimental | Dietary Supplement: Highland barley β-glucan dietary supplementParticipants will be given oral liquids mainly containing highland barley β-glucan once daily for 8 weeks followed by comprehensive physical and clinical examinations. |
| Placebo group | Placebo comparator | Other: Placebo controlsParticipants will be given oral liquids mainly containing Corn starch once daily for 8 weeks followed by comprehensive physical and clinical examinations. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highland barley β-glucan dietary supplement100 mL oral liquid mainly containing highland barley β-glucan once daily for 8 weeks | Dietary supplement | Highland barley β-glucan group |
| Placebo controlsPlacebo with a similar appearance and taste to highland barley β-glucan supplement | Other | Placebo group |
Primary outcome
fasting venous plasma glucose
Time frame: baseline and after 8-week intervention
changes of fasting venous plasma glucose levels
plasma glucose 2 h after an oral glucose load
Time frame: baseline and after 8-week intervention
changes of plasma glucose levels 2 h after an oral glucose load
glycosylated hemoglobin
Time frame: baseline and after 8-week intervention
changes of glycosylated hemoglobin levels
4 secondary outcomes
gut microbiota
Time frame: baseline and after 8-week intervention
microbial metabolites
Time frame: baseline and after 8-week intervention
Matsuda index
Time frame: baseline and after 8-week intervention
flow-mediated dilation
Time frame: baseline and after 8-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
Related trials for Hyperglycemia
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highland barley β-glucan dietary supplement in people with Hyperglycemia and Insulin Sensitivity, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting venous plasma glucose (time frame: baseline and after 8-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.