Prediabetes
Conditions
Brief summary
This study will implement a four-week dietary intervention among middle-aged and older adults with pre-diabetes. Participants assigned to the intervention arm will replace their usual cooking oil with diacylglycerol (DAG) oil, while those in the control arm will consume colza oil. All other lifestyle behaviors will be maintained without modification. The trial will determine the impact of DAG oil consumption on glycemic regulation, lipid metabolism, and body composition in this high-risk population.
Interventions
COMBINATION_PRODUCTDiacylglycerol oil
This study will implement a four-week dietary intervention in which participants assigned to the intervention group will replace their habitual cooking oil with diacylglycerol (DAG) oil. All other lifestyle behaviors will be maintained without modification.
COMBINATION_PRODUCTColza Oil
Participants assigned to the control group will consume colza oil as their cooking oil throughout a four-week dietary intervention. No other lifestyle habits or dietary behaviors will be altered.
Sponsors
The First Affiliated Hospital of Guangdong Pharmaceutical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 40-75 years. 2. Diagnosed with prediabetes according to American Diabetes Association (ADA) criteria: including fasting plasma glucose (FPG) levels of 5.6-6.9 mmol/L, and/or 2-hour postprandial glucose (OGTT-2h) levels of 7.8-11.1 mmol/L, and/or glycated hemoglobin (HbA1c) levels of 5.7%-6.4%. 3. Body mass index (BMI) ≥ 24 kg/m². 4. No plans to relocate or travel extensively in the next three months. 5. Willing to consume all study-provided meals throughout the intervention. 6. Willing and able to provide written informed consent.
Exclusion criteria
1. Diagnosis of diabetes (Type 1 or Type 2). 2. Current use of any glucose-lowering medication. 3. Use of appetite suppressants or hormonal medications. 4. History of bariatric surgery, or weight change \>5% in the past 3 months. 5. Alcohol consumption \>40 g/day. 6. Use of antibiotics, probiotics, or prebiotics within the past 3 months. 7. Pregnancy, lactation or planning pregnancy. 8. History of severe cardiovascular disease, malignancy, autoimmune disease, cognitive impairment, or severe dysfunction of thyroid, liver, kidney, or digestive system. 9. Inability to comprehend information, communicate effectively, or comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Glucose Monitoring (CGM) Data | up to 4 weeks | At baseline, and 4 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fasting blood glucose | At baseline and after 4 weeks of intervention | At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose. |
| lipid metabolism | At baseline and after 4 weeks of intervention | At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride. |
| HbA1c | At baseline and after 4 weeks of intervention | At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c. |
| weight | up to 4 weeks | At baseline, and 4 weeks, investigators will examine weight. |
| TIR (time in range) | At baseline and after 4 weeks of intervention | TIR refers to the time when blood glucose is controlled within a reasonable ( target ) range (3.9\ 10.0 mmol/L), measured by continuous glucose monitoring at baseline and 4 weeks. |
| sleep quality | up to 4 weeks | Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), which comprises seven components (A through G), each scored on a scale of 0-3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
| blood pressure | up to 4 weeks | At baseline, and 4 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor. |
| intestinal bacteria | up to 4 weeks | At baseline, and 4 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria. |
Countries
China
Contacts
Primary ContactQiuYe Dr. Lan
Outcome results
None listed