Pre-diabeticNCT03495362
The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients
A study testing Yeast Beta-glucan in people with Pre-diabetic, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.However,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pre-diabetic
- What is being tested?
- Yeast Beta-glucan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2018to Mar 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-65 years
- Meet the pre-diabetes diagnostic criteria recommended by World Health Organization (WHO) in 1999
Who cannot join
- Allergic to test substances
- Known severe heart, liver, kidney, autoimmune diseases, psychosis, nervous system, hematopoietic system, endocrine and other systemic diseases
- Known acute disease, common cold, metabolic diseases, chronic inflammation, infectious diseases, and heavy physical labor recently
- Usage of antihyperlipidemia or antihypertension, and other drugs may influence the interventional effect last two weeks
- Unable to cooperate with researchers or maintain ordinary dietary habit
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Liegang Liu, MD, PhD, +86-27-83650522, liegangliu@gmail.com
Shufang Xu, PhD
About this study
Official title: The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients: a Randomized Double-blind Trial
There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.However,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. This is a randomized double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of prediabetic patients. Firstly, the investigators will go into the efficacy of yeast beta-glucan on improving the clinical symptoms of prediabetics. Secondly, the investigators will study the mechanism of yeast beta-glucan on enhancing the immune function and improving the inflammatory response.
- Conditions
- Pre-diabetic
- Being tested
- Yeast Beta-glucan, Placebo
- Keywords
- Yeast Beta-glucan, Immune Function, Prediabetes, Gut Microbiota
- Medical subject headings
- Glucose Intolerance, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yeast Beta-glucanDietary supplement
Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
PlaceboOther
Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Ingredients: yeast beta-glucan, and capsule shell Capsule, per capsule with 500mg insoluble beta-glucan, twice a day, 1 capsule each time.
The intervention period is about 3 months. Receives: Dietary Supplement: Yeast Beta-glucan |
| Placebo group | Placebo comparator | Ingredients: starch, and capsule shell Capsule, per capsule with 500mg starch, twice a day, 1 capsule each time. The intervention period is about 3 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs)
Extract and isolate PBMCs from participants. Using flow cytometry to detect the differentiation rates of some PBMCs（Peripheral Blood Mononuclear Cells）inculding T, B, NK, CD4+, CD8+, CD19+, CD138+, CD3+ and CD45+ cells
Measured: At 0 week, 6th week, 12th week in the intervention period.
Changes in inflammatory factors
Using ELISA to detect the expression level of TNF-α, IL-6, IL-1β, IL-12, IL-10, TGF-β
Measured: At 0 week, 6th week, 12th week in the intervention period.
Changes in blood glucose level
FPG(fasten plasma glucose), OGTT（oral glucose tolerance test）
Measured: At 0 week, 12th week in the intervention period.
Changes in gut microbiota
High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform.
Measured: At 0 week, 6th week, 12th week in the intervention period.
Changes in RTI(respiratory tract infection)
Observe the clinical symptoms of respiratory infections in two groups of patients
Measured: Every week across the intervention peroid，an average of 3 months.
Changes in islet function
C-peptide level
Measured: At 0 week, 12th week in the intervention period.
Secondary outcomes (3)
Changes in SCFA (short chain fatty acids)
Using GC-MS to detect fecal and plasma SCFA
Measured: At 0 week, 6th week, 12th week in the intervention period.
Changes in blood lipids profile
Fasting plasma Total cholesterol, Low Density Lipoprotein, High Density Lipoprotein and triglycerides.
Measured: At 0 week, 12th week in the intervention period.
Changes in hepatorenal function
Using automatic biochemical analyzer to detect creatinine, urea nitrogen, alanine aminotransferase, aspartate aminotransferase and so on
Measured: At 0 week, 12th week in the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start13 Mar 2018
- Primary completionNov 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabeticStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495362
- Sponsor's protocol ID
- CHW20180201
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insoluble Yeast Beta-glucan Intake on Pre-diabetic Patients: a Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT03495362
- Acronym / sponsor ID
- CHW20180201
- Conditions
- Pre-diabetic
- Keywords
- Yeast Beta-glucan, Immune Function, Prediabetes, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 12 Apr 2018 (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.
There is a lot of evidence to show that the yeast beta-glucan has immunomodulatory, anti-inflammatory, anti-infective effects.However,few work was done on the relationship between yeast bata-glucan and the immune function of diabetic patients. This is a randomized double-blind trial, aiming to study the effect of yeast beta-glucan on immune system of prediabetic patients. Firstly, the investigators will go into the efficacy of yeast beta-glucan on improving the clinical symptoms of prediabetics. Secondly, the investigators will study the mechanism of yeast beta-glucan on enhancing the immune function and improving the inflammatory response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Yeast Beta-glucanIngredients: yeast beta-glucan, and capsule shell Capsule, per capsule with 500mg insoluble beta-glucan, twice a day, 1 capsule each time. The intervention period is about 3 months. |
| Placebo group | Placebo comparator | Other: PlaceboIngredients: starch, and capsule shell Capsule, per capsule with 500mg starch, twice a day, 1 capsule each time. The intervention period is about 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 18-65 years
- Meet the pre-diabetes diagnostic criteria recommended by World Health Organization (WHO) in 1999
Key exclusion criteria (5 listed)
- Allergic to test substances
- Known severe heart, liver, kidney, autoimmune diseases, psychosis, nervous system, hematopoietic system, endocrine and other systemic diseases
- Known acute disease, common cold, metabolic diseases, chronic inflammation, infectious diseases, and heavy physical labor recently
- Usage of antihyperlipidemia or antihypertension, and other drugs may influence the interventional effect last two weeks
- Unable to cooperate with researchers or maintain ordinary dietary habit
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 |
|---|---|---|
| Yeast Beta-glucanTwice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. | Dietary supplement | Intervention group |
| PlaceboTwice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements. | Other | Placebo group |
Primary outcome
Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs)
Time frame: At 0 week, 6th week, 12th week in the intervention period.
Extract and isolate PBMCs from participants. Using flow cytometry to detect the differentiation rates of some PBMCs（Peripheral Blood Mononuclear Cells）inculding T, B, NK, CD4+, CD8+, CD19+, CD138+, CD3+ and CD45+ cells
Changes in inflammatory factors
Time frame: At 0 week, 6th week, 12th week in the intervention period.
Using ELISA to detect the expression level of TNF-α, IL-6, IL-1β, IL-12, IL-10, TGF-β
Changes in blood glucose level
Time frame: At 0 week, 12th week in the intervention period.
FPG(fasten plasma glucose), OGTT（oral glucose tolerance test）
Changes in gut microbiota
Time frame: At 0 week, 6th week, 12th week in the intervention period.
High-throughput 16S DNA gene amplicon sequencing performed on the Illumina HiSeq platform.
Changes in RTI(respiratory tract infection)
Time frame: Every week across the intervention peroid，an average of 3 months.
Observe the clinical symptoms of respiratory infections in two groups of patients
Changes in islet function
Time frame: At 0 week, 12th week in the intervention period.
C-peptide level
3 secondary outcomes
Changes in SCFA (short chain fatty acids)
Time frame: At 0 week, 6th week, 12th week in the intervention period.
Changes in blood lipids profile
Time frame: At 0 week, 12th week in the intervention period.
Changes in hepatorenal function
Time frame: At 0 week, 12th week in the intervention period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yeast Beta-glucan in people with Pre-diabetic, run by Huazhong University of Science and Technology 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 2 inclusion and 5 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 12 Apr 2018. 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?
Contact Liegang Liu, MD, PhD (+86-27-83650522, liegangliu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the differentiation rates of some peripheral blood mononuclear cells (PBMCs) (time frame: At 0 week, 6th week, 12th week in the intervention period.). The study lists 6 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 12 Apr 2018.