Study on the effect of two compositions in regulating postprandial blood glucose response

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300076388

Enrollment

Unknown

Registered

2023-10-07

Start date

2023-11-01

Completion date

Unknown

Last updated

2023-10-09

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

Conditions

diabetes mellitus

Interventions

Short-term intervention group:Supplement A and B interventions are given for one month each

Single intervention group:Participants received four interventions (individual slices of bread

Supplement A with bread slices

Supplement B with bread slices

Supplement C with bread slices)

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Study on the effect of single intake on postprandial blood glucose: 1) Healthy men or women aged between 18-40 years 2) BMI ranges from 18 to 25 kg/m2 3) No previous diagnosis of diabetes or pre-diabetes 4) Fasting blood glucose: 3.9 to 5.5 mmol/L (70-100mg/dL) 5) Not taking any medication for diabetes or insulin resistance 6) Willing to provide informed written consent to participate in the study Short-term intervention affects dynamic postprandial blood glucose response: 1) Aged 30-60 and diagnosed with pre-diabetes (impaired fasting blood sugar or impaired glucose tolerance) within the past 12 months 2) Pre-diabetes was defined as fasting blood glucose concentration = 6.1 and < 7.0 mmol/L, followed by 2 hours of glucose load after blood glucose concentration < 7.8 mmol/L, or fasting blood glucose < 7.0 mmol/L, and glucose concentration = 7.8 and &lt after 2 hours of glucose loading; 11.1 mmol/L

Exclusion criteria

Exclusion criteria: Study on the effect of single intake on postprandial blood glucose: 1) Abnormal results of liver function test (alanine aminotransferase and aspartate aminotransferase), renal function test (blood urea nitrogen and creatinine), routine blood test, urine analysis, stool occult blood test or electrocardiogram 2) Pregnant or lactating women 3) Participate in clinical trials within the last 3 months 4) Malignant tumor history or current malignant tumor 5) A history of drug dependence, substance abuse or alcoholism 6) History of drug or food allergies or allergies to any component of the test product 7) A known history of primary disease in a major organ, such as the heart, liver, or kidneys, or a history of digestive, metabolic, neurological, or psychiatric disorders 8) Have taken drugs known to cause organ damage in the previous 3 months 9) Have taken any medication in the past 2 weeks Short-term intervention affects dynamic postprandial blood glucose response: 1) Individuals with type 1 or type 2 diabetes or impaired kidney function, individuals with gastrointestinal disorders (celiac disease, inflammatory bowel disease), pregnant women, smokers, people who have made significant dietary or lifestyle changes in the past three months

Design outcomes

Primary

Measure	Time frame
postprandial glucose;	—

Secondary

Measure	Time frame
1, 5-anhydroglucosol;fructosamine;glycosylated hemoglobin;insulin;	—

Countries

China

Contacts

Public ContactJin Sun

Medical College of Qingdao University

sunj@qdu.edu.cn+86 181 5155 9959

Outcome results

None listed

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