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Not yet recruitingNCT07289880Updated Dec 24, 2025

Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes

An interventional study of Diacylglycerol oil and Colza Oil in Prediabetes, sponsored by The First Affiliated Hospital of Guangdong Pharmaceutical University. Not yet recruiting at 1 site in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by The First Affiliated Hospital of Guangdong Pharmaceutical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Prediabetes

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03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's planned enrollment of 40 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

The First Affiliated Hospital of Guangdong Pharmaceutical University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    DAG Oil Group

    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.

    Combination Product: Diacylglycerol oil

  • Active comparator
    Control Group

    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.

    Combination Product: Colza Oil

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.

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What researchers measure

Primary outcomes

  1. Continuous Glucose Monitoring (CGM) Data

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

    Time frame: up to 4 weeks

Secondary outcomes

  1. weight

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

    Time frame: up to 4 weeks

  2. fasting blood glucose

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

    Time frame: At baseline and after 4 weeks of intervention

  3. lipid metabolism

    At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride.

    Time frame: At baseline and after 4 weeks of intervention

  4. HbA1c

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

    Time frame: At baseline and after 4 weeks of intervention

  5. intestinal bacteria

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

    Time frame: up to 4 weeks

  6. TIR (time in range)

    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.

    Time frame: At baseline and after 4 weeks of intervention

  7. sleep quality

    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.

    Time frame: up to 4 weeks

  8. blood pressure

    At baseline, and 4 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor.

    Time frame: up to 4 weeks

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Study locations

1 site
  • Beijing Street
    Guangzhou, Guangdong 510000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07289880
Lead sponsor
The First Affiliated Hospital of Guangdong Pharmaceutical University
Responsible party
Qiu-ye Lan (Associate Researcher, Guangdong Pharmaceutical University) — Principal investigator
First posted
Dec 17, 2025
Start date
Dec 30, 2025 (estimated)
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Dec 24, 2025

Study contacts

QiuYe Dr. Lan
Contact
lanqiuye@gdpu.edu.cn
+86-18520395821

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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