Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes

The First Affiliated Hospital of Guangdong Pharmaceutical University

Status: Not yet enrolling

Conditions: Prediabetes

Treatments: Combination Product: Diacylglycerol oil; Combination Product: Colza Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07289880

FirstAHGuangdong

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

DAG Oil Group

Experimental group

Description:

A four-week dietary intervention will be implemented, during which participants assigned to the intervention group will replace their habitual cooking oil with diacylglycerol (DAG) oil.

Treatment:

Combination Product: Diacylglycerol oil

Control Group

Active Comparator group

Description:

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.

Treatment:

Combination Product: Colza Oil