Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

January 28, 2026 updated by: An Pan, Huazhong University of Science and Technology

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes: A Randomized Double-Blind Controlled Trial

This study is a randomized, double-blind, placebo-controlled trial involving 2,500 individuals aged 40-79 with type 2 diabetes (T2D). The trial includes a 2-year intervention period followed by a 3-year post-intervention follow-up. The primary objective is to investigate (a) the effect of daily supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) on glycemic control in patients with T2D and (b) whether daily supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) reduces the predicted 10 year risk of atherosclerotic cardiovascular disease (ASCVD) in patients with T2D. The secondary objectives include evaluating the effects of vitamin D3 or yeast β-glucan supplementation on cardiometabolic risk factors, inflammatory markers, and liver and kidney function indicators, and assessing whether such supplementation reduces the risk of cardiovascular disease, microvascular complications and mortality over the 3-year post-intervention period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this randomized, double-blind, placebo-controlled trial, with a 2×2 factorial design in individuals with type 2 diabetes (T2D), is to investigate (a) the effect of daily dietary supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) on glycemic control in patients with T2D and (b) whether vitamin D3 (1600 IU) or yeast β-glucan (600 mg) supplementation reduces the predicted 10 year risk of atherosclerotic cardiovascular disease (ASCVD) in patients with T2D. Approximately 2,500 subjects aged 40-79 with T2D will be included in this study. Eligible participants will be randomly assigned to one of four groups: (1) daily vitamin D3 (1600 IU) and yeast β-glucan (600 mg); (2) daily vitamin D3 (1600 IU) and placebo for yeast β-glucan; (3) daily placebo for vitamin D3 and yeast β-glucan (600 mg); or (4) daily placebo for vitamin D3 and placebo for yeast β-glucan. At baseline, questionnaires will be administered to collect data on sociodemographic factors, lifestyle habits, health status, cognitive function, and medical conditions, et al. Participants will also undergo physical measurements, and blood, urine, and feces samples will be collected at study centers. The study includes a 2-year intervention period followed by a 3-year post-intervention follow-up. Participants in all groups will take four capsules daily for 2 years: two capsules containing either vitamin D or its placebo and two capsules containing either yeast β-glucan or its placebo. During the 2-year intervention period, questionnaires, physical measurements, and sample collection will be conducted at 6, 12, and 24 months. This trial will also evaluate the effects of supplementation on cardiometabolic risk factors, inflammatory markers, and liver and kidney function indicators, and assess whether it reduces the risk of cardiovascular disease, microvascular complications, and mortality over the 3-year post-intervention period, providing scientific evidence for the health effects of vitamin D or yeast β-glucan in the T2D population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • Guangxi Medical College
        • Contact:
          • Qiuli Chen
    • Hebei
      • Tangshan, Hebei, China
        • Recruiting
        • Kailuan General Hospital
        • Contact:
          • Shuohua Chen
    • Hubei
      • Shiyan, Hubei, China
        • Recruiting
        • Sinopharm Dongfeng General Hospital
        • Contact:
          • Kun Yang
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Huazhong University of Science and Technology
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan University
        • Contact:
          • Jiayuan Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Type 2 diabetes mellitus diagnosed by a physician based on the diagnostic criteria outlined in the Guideline for the Prevention and Treatment of Diabetes Mellitus in China (2024 Edition);
  2. Men or women aged 40-79 years;
  3. Convenient access to the study centers and permanent residence in the vicinity for the next five years;
  4. Voluntary participation and signed written informed consent.

Exclusion Criteria:

  1. History of clinical cardiovascular disease (including myocardial infarction, treatment or hospitalization for heart failure, stroke, and coronary revascularization) within the past 6 months;
  2. History of severe diabetic microvascular complications (diabetic nephropathy with an estimated glomerular filtration rate (eGFR) < 30 mL/(min·1.73m²), proliferative diabetic retinopathy, confirmed diabetic peripheral neuropathy with abnormal nerve conduction studies or small fiber neuropathy testing);
  3. History of cancer, excluding non-melanoma skin cancer or cancers with a favorable prognosis;
  4. History of kidney stones, hypercalcemia, or hyperparathyroidism;
  5. History of severe liver disease, severe kidney disease, severe gastrointestinal disease, severe infectious diseases, severe sarcoidosis or other granulomatous diseases, severe mental illness, or any other condition considered unsuitable for participation judged by the clinic team;

  6. Laboratory evaluation:

    • Blood calcium levels greater than or equal to the normal range for the clinical site's laboratory;
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels higher than 3 times the normal range for the clinical site's laboratory;
    • eGFR < 30 mL/(min·1.73m²);
  7. Individuals currently taking vitamin D supplements (>400 IU/day), calcium supplements (>600 mg/day), yeast β-glucan supplements (>250 mg/day), or those with a history of allergy or intolerance to vitamin D or prebiotic products;
  8. Participation in other clinical trials within the past 3 months;
  9. Planning to become pregnant within the next five years, or currently pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Vitamin D + yeast β-glucan
Drug: Vitamin D3
Vitamin D3(cholecalciferol),1600 IU per day.
Other Names:
  • cholecalciferol
Dietary supplement: yeast β-glucan
yeast β-glucan, 600mg per day.
Active Comparator: Vitamin D + yeast β-glucan placebo
Drug: Vitamin D3
Vitamin D3(cholecalciferol),1600 IU per day.
Other Names:
  • cholecalciferol
Dietary supplement: yeast β-glucan placebo
yeast β-glucan placebo
Active Comparator: yeast β-glucan +Vitamin D placebo
Dietary supplement: Vitamin D placebo
Vitamin D placebo
Dietary supplement: yeast β-glucan
yeast β-glucan, 600mg per day.
Placebo Comparator: Vitamin D placebo + yeast β-glucan placebo
Dietary supplement: Vitamin D placebo
Vitamin D placebo
Dietary supplement: yeast β-glucan placebo
yeast β-glucan placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 24 months
Change in HbA1c from baseline to the 24-month visit
24 months
Cardiovascular disease risk
Time Frame: 24 months
Change in 10-year ASCVD risk score from baseline to the 24-month visit, assessed using China-PAR score, with a score range of 0-100%, where a higher score means a higher ASCVD risk
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major cardiovascular events
Time Frame: 60 months
Time to the first occurrence of any of the following: myocardial infarction, hospitalized or treated heart failure, stroke, revascularization of coronary arteries, or cardiovascular deaths
60 months
All-cause mortality
Time Frame: 60 months
Deaths from any causes
60 months
Microvascular disease
Time Frame: 60 months
Time to the first occurrence of any of the following: nephropathy, retinopathy, or neuropathy
60 months
Blood 25(OH)D
Time Frame: 24 months
Change in blood 25(OH)D concentrations from baseline to the 24-month visit
24 months
Change in fasting plasma glucose
Time Frame: 24 months
Change in fasting plasma glucose from baseline to the 24-month visit. The value is reported in millimole per liter (mmol/L).
24 months
Change in fasting C-peptide
Time Frame: 24 months
Change in fasting C-peptide from baseline to the 24-month visit. The value is reported in nanogram per milliliter (ng/mL).
24 months
Change in insulin
Time Frame: 24 months
Change in insulin from baseline to the 24-month visit. The value is reported in microunit per milliliter (μU/mL).
24 months
Change in HOMA-IR
Time Frame: 24 months
Change in HOMA-IR from baseline to the 24-month visit. HOMA-IR = [Fasting Serum Insulin (μU/mL) × Fasting Plasma Glucose (mmol/L)] / 22.5. Lower values indicate better insulin sensitivity.
24 months
Change in Lipid profile
Time Frame: 24 months
Change in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to the 24-month visit. These values are reported in millimole per liter (mmol/L).
24 months
Change in Liver function markers
Time Frame: 24 months
Change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), a nd gamma-glutamyl transferase (GGT) from baseline to the 24-month visit. These values are reported in units per liter (U/L).
24 months
Change in serum creatinine
Time Frame: 24 months
Change in serum creatinine from baseline to the 24-month visit. The value is reported in micromole per liter (μmol/L).
24 months
Change in cystatin C
Time Frame: 24 months
Change in cystatin C from baseline to the 24-month visit. The value is reported in milligram per liter (mg/L).
24 months
Change in eGFR
Time Frame: 24 months
Change in estimated glomerular filtration rate (eGFR) from baseline to the 24-month visit. The CKD-EPI (2009) method to estimate eGFR value. The value is reported in milliliter per minute per 1.73 square meters (mL/min/1.73 m²).
24 months
Change in blood calcium
Time Frame: 24 months
Change in blood calcium from baseline to the 24-month visit. The value is reported in millimole per liter (mmol/L).
24 months
Change in body weight
Time Frame: 24 months
Change in body weight from baseline to the 24-month visit. The value is reported in kilogram (kg).
24 months
Change in BMI
Time Frame: 24 months
Change in body mass index (BMI) from baseline to the 24-month visit. BMI = Body Weight (kg) / [Height (m)]^2. The value is reported in kilogram per square meter (kg/m^2).
24 months
Change in waist circumference
Time Frame: 24 months
Change in waist circumference from baseline to the 24-month visit. The value is reported in centimeter (cm).
24 months
Change in waist-to-hip ratio
Time Frame: 24 months
Change in waist-to-hip ratio from baseline to the 24-month visit. Waist-to-hip ratio = Waist Circumference (cm) / Hip Circumference (cm). Higher values indicate greater central adiposity.
24 months
Change in blood pressure
Time Frame: 24 months
Change in systolic and diastolic blood pressure from baseline to the 24-month visit. The values are reported in millimeters of mercury (mmHg).
24 months
Change in grip strength
Time Frame: 24 months
Change in grip strength from baseline to the 24-month visit, assessed using a handgrip dynamometer. The value is reported in kilogram (kg).
24 months
Change in FRAIL scale
Time Frame: 24 months
FRAIL scale comprises five domains: fatigue, resistance, ambulation, illnesses, and weight loss. Each item is scored as 0 or 1, yielding a total score ranging from 0 to 5, with higher scores indicating greater frailty. Based on the total score, patients were categorized as robust (0 points), pre-frail (1-2 points), or frail (3-5 points).
24 months
Change in C-reactive protein
Time Frame: 24 months
Change in C-reactive protein (CRP) from baseline to the 24-month visit. The value is reported in milligram per liter (mg/L).
24 months
Change in procalcitonin
Time Frame: 24 months
Change in procalcitonin from baseline to the 24-month visit. The value is reported in nanogram per milliliter (ng/mL).
24 months
Change in interleukin-6
Time Frame: 24 months
Change in interleukin-6 (IL-6) from baseline to the 24-month visit. The value is reported in picogram per milliliter (pg/mL).
24 months
Bone mineral density
Time Frame: 24 months
Change in bone mineral density from baseline to the 24-month visit, including but not limited to Speed of Sound (SOS), T-score, and Z-score. SOS is reported in meters per second （m/s). T-score and Z-score have no dimensional units.
24 months
Change in baPWV
Time Frame: 24 months
Change in brachial-Ankle Pulse Wave Velocity (baPWV) from baseline to the 24-month visit. The value is reported in centimeters per second (cm/s).
24 months
Change in ABI
Time Frame: 24 months
Change in Ankle-Brachial Index (ABI) from baseline to the 24-month visit. ABI=Systolic blood pressure of the ankle (mmHg) / Higher values of bilateral arm systolic pressure (mmHg).
24 months
Change in LSM
Time Frame: 24 months
Change in stiffness measurement (LSM) from baseline to the 24-month visit, assessed by transient elastography (FibroTouch). The value is reported in kilopascal (kPa).
24 months
Change in UAP
Time Frame: 24 months
Change in Ultrasound Attenuation Parameter (UAP) from baseline to the 24-month visit, assessed by transient elastography (FibroTouch). The value is reported in Decibel per Megahertz per Centimeter (dB/MHz/cm).
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other events
Time Frame: 60 months
Incidence of other cardiovascular diseases (not listed above), cancer, infectious diseases and falls
60 months
Change in Health-related quality of life
Time Frame: 24 months
Change in health-related quality of life from baseline to the 24-month visit, assessed using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, with a score range of 0-100, where a higher score means higher health-related quality of life
24 months
Change in Cognitive function (MoCA)
Time Frame: 24 months
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a one-page 30-point test. Scores range from 0 to 30, with a score of 26 or above considered normal. The change in score from baseline to 24 months will be calculated.
24 months
Change in Cognitive function (MMSE)
Time Frame: 24 months
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The MMSE is a 30-point questionnaire. Scores range from 0 to 30, with different cut-off points for normal cognition based on education level: >17 for illiterate, >20 for individuals with ≤6 years of education, and >24 for individuals with >6 years of education. The change in score from baseline to 24 months will be calculated.
24 months
Change in depressive mood score
Time Frame: 24 months
Change in depressive symptom severity from baseline to the 24-month visit, measured by the Patient Health Questionnaire-9 (PHQ-9) score, with a score range of 0-27, where a higher score means more severe depressive symptoms.
24 months
Change in anxiety score
Time Frame: 24 months
Change in anxiety symptom severity from baseline to the 24-month visit, measured by the Generalized Anxiety Disorder-7 (GAD-7) score, with a score range of 0-21, where a higher score means more severe anxiety symptoms and clinical cut point for anxiety disorder was 10 points.
24 months
Change in Sleep quality
Time Frame: 24 months
Change in sleep quality from baseline to the 24-month visit, assessed using the Pittsburgh Sleep Quality Index (PSQI), with a score range of 0-21, where a higher score means worse sleep quality.
24 months
Change in BF%
Time Frame: 24 months
Change in body fat percentage (BF%) from baseline to the 24-month visit.
24 months
Change in fat mass
Time Frame: 24 months
Change in fat mass from baseline to the 24-month visit. The value is reported in kilogram (kg).
24 months
Change in fat-free mass
Time Frame: 24 months
Change in fat-free mass from baseline to the 24-month visit. The value is reported in kilogram (kg).
24 months
Concentration of blood metabolites
Time Frame: 24 months
Blood metabolites, including, but not limited to, fatty acids and lipoprotein particles, quantified by liquid chromatography-tandem mass spectrometry (LC-MS/MS), are reported in mmol/L.
24 months
Metagenomic analysis of the gut microbiota
Time Frame: 24 months
The diversity of the gut microbiota will be assessed by high-quality whole-metagenomic sequencing
24 months
DNA methylation level
Time Frame: 24 months
The relative change in DNA methylation level quantified by pyrosequencing, reported as percentage methylation at specific CpG sites
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huazhong University of Science and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: An Pan, PHD, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VD, Yeast β-Glucan in Diabetes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) sharing will need to be approved by the Institutional Review Board (IRB) and the study investigators with individual specific project request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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