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NCT Number: NCT07289880

Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 40-75 years.
  • 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%.
  • Body mass index (BMI) ≥ 24 kg/m².
  • No plans to relocate or travel extensively in the next three months.
  • Willing to consume all study-provided meals throughout the intervention.
  • Willing and able to provide written informed consent.

Exclusion criteria

  • Diagnosis of diabetes (Type 1 or Type 2).
  • Current use of any glucose-lowering medication.
  • Use of appetite suppressants or hormonal medications.
  • History of bariatric surgery, or weight change >5% in the past 3 months.
  • Alcohol consumption >40 g/day.
  • Use of antibiotics, probiotics, or prebiotics within the past 3 months.
  • Pregnancy, lactation or planning pregnancy.
  • History of severe cardiovascular disease, malignancy, autoimmune disease, cognitive impairment, or severe dysfunction of thyroid, liver, kidney, or digestive system.
  • Inability to comprehend information, communicate effectively, or comply with the study protocol.

Treatment and study plan

Diacylglycerol oil

Combination Product

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.

Colza Oil

Combination Product

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.

Primary outcomes

  1. Continuous Glucose Monitoring (CGM) Data

    Time frame: up to 4 weeks

    At baseline, and 4 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants.

Secondary outcomes

  1. weight

    Time frame: up to 4 weeks

    At baseline, and 4 weeks, investigators will examine weight.

  2. fasting blood glucose

    Time frame: At baseline and after 4 weeks of intervention

    At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.

  3. lipid metabolism

    Time frame: 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.

  4. HbA1c

    Time frame: At baseline and after 4 weeks of intervention

    At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.

  5. intestinal bacteria

    Time frame: up to 4 weeks

    At baseline, and 4 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria.

  6. TIR (time in range)

    Time frame: 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.

  7. sleep quality

    Time frame: 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.

  8. blood pressure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

QiuYe Dr. Lan

CONTACT

[email protected]

+86-18520395821

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangdong Pharmaceutical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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