PrediabetesNCT07289880
Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes
A study testing Diacylglycerol oil and Colza Oil in people with Prediabetes, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Diacylglycerol oil and Colza Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Street
Guangzhou, Guangdong, 510000
Yawen Ms. Liang, +86-18718707135, lyaw0401@163.com
About this study
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.
- Conditions
- Prediabetes
- Being tested
- Diacylglycerol oil, Colza Oil
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diacylglycerol oilCombination 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 OilCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| DAG Oil Group | Experimental | 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. Receives: Combination Product: Diacylglycerol oil |
| Control Group | Active comparator | 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. Receives: Combination Product: Colza Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitoring (CGM) Data
At baseline, and 4 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants.
Measured: up to 4 weeks
Secondary outcomes (8)
weight
At baseline, and 4 weeks, investigators will examine weight.
Measured: up to 4 weeks
fasting blood glucose
At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.
Measured: At baseline and after 4 weeks of intervention
lipid metabolism
At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine total cholesterol, low density lipoprotein, high density lipoprotein, triglyceride.
Measured: At baseline and after 4 weeks of intervention
HbA1c
At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.
Measured: At baseline and after 4 weeks of intervention
intestinal bacteria
At baseline, and 4 weeks, investigators will use 16S rRNA pyrosequencing to examine intestinal bacteria.
Measured: up to 4 weeks
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.
Measured: At baseline and after 4 weeks of intervention
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.
Measured: up to 4 weeks
blood pressure
At baseline, and 4 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start30 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangdong Pharmaceutical University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Principal investigator, Qiu-ye Lan, Guangdong Pharmaceutical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289880
- Sponsor's protocol ID
- School of Public Health
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes
- ClinicalTrials.gov ID
- NCT07289880
- Acronym / sponsor ID
- School of Public Health
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangdong Pharmaceutical UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAG Oil Group | Experimental | Combination Product: Diacylglycerol oilA 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. |
| Control Group | Active comparator | Combination Product: Colza OilParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diacylglycerol oilThis 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 product | DAG Oil Group |
| Colza OilParticipants 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 | Control Group |
Primary outcome
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.
8 secondary outcomes
weight
Time frame: up to 4 weeks
fasting blood glucose
Time frame: At baseline and after 4 weeks of intervention
lipid metabolism
Time frame: At baseline and after 4 weeks of intervention
HbA1c
Time frame: At baseline and after 4 weeks of intervention
intestinal bacteria
Time frame: up to 4 weeks
TIR (time in range)
Time frame: At baseline and after 4 weeks of intervention
sleep quality
Time frame: up to 4 weeks
blood pressure
Time frame: up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diacylglycerol oil and Colza Oil in people with Prediabetes, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QiuYe Dr. Lan (+86-18520395821, lanqiuye@gdpu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Glucose Monitoring (CGM) Data (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.