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Mechanisms of the Effects of Food Bioactive Components on Gastrointestinal Health under Different Physiological States

Study on the Regulatory Effects of Dietary Supplement ß-Glucan and Vitamin D on the Health of Prediabetic Population

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109155
Enrollment
Unknown
Registered
2025-09-12
Start date
2025-03-21
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetic

Interventions

Intervention group 1:Breakfast group: 250 mg/person/day of ß-glucan
Intervention group 2:Dinner group: 250 mg/person/day of ß-glucan
Intervention group 3:1360 IU/person/day of vitamin D
Intervention group 4:680 IU/person/day of vitamin D

Sponsors

Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
57 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age: 60–90 years; 2. Prediabetes group: Fasting blood glucose (FBG): 6.1–7.0 mmol/L (may be extended to 5.6–7.0 mmol/L); or Oral glucose tolerance test, 2 hours (OGTT-2h): 7.8–11.1 mmol/L; or HbA1c: 5.7%–6.4%; 3. Healthy group (sampling only, without intervention): FBG: 3.9–6.1 mmol/L; or OGTT-2h: 3.9–7.8 mmol/L; 4. During the study period, participants’ lifestyle will remain stable (including physical activity level and daily routine).

Exclusion criteria

Exclusion criteria: 1. Diabetes mellitus: Newly diagnosed or existing diabetes mellitus (FPG > 7.0 mmol/L and/or OGTT-2h blood glucose > 11.1 mmol/L, and/or currently receiving hypoglycemic therapy). 2. Other severe health conditions: Newly diagnosed cardiovascular or cerebrovascular diseases within the past year, including heart disease, unstable angina, myocardial infarction, or stroke; Uncontrolled or untreated hypertension [systolic blood pressure (SBP) =160 mmHg and/or diastolic blood pressure (DBP) =100 mmHg] (criteria may be relaxed if the sample size is limited); Severe hepatic dysfunction, defined as alanine aminotransferase (ALT) greater than two times the upper limit of normal (40 IU/L); Severe renal dysfunction, defined as serum creatinine >133 µmol/L in men or >115 µmol/L in women; Other diseases: malignancy, history of major gastrointestinal surgery, or thyroid dysfunction. 3. Medication use: Use of, or planned use of, the following medications within the past month: calcium supplements, vitamin D, ß-glucan, antibiotics, antidiabetic drugs, gastric acid inhibitors, or probiotics.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;Glucose tolerance;Glycated hemoglobin;25-hydroxyvitamin D;

Secondary

MeasureTime frame
Fecal gut microbiota;Serum metabolites;

Countries

China

Contacts

Public ContactZhenyu Lan

Jiangbin Hospital of Guangxi Zhuang Autonomous Region and Chinese academy of agricultural sciences and Jiangbin Hospital of Guangxi Zhuang Autonomous Region

543613073@qq.com+86 150 0108 5526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026