Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes

NCT ID: NCT07289880

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-30

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Diacylglycerol oil

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Colza Oil

Intervention Type 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.

Interventions

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Diacylglycerol 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.

Intervention Type COMBINATION_PRODUCT

Colza 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role lead

Responsible Party

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Qiu-ye Lan

Associate Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Street

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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QiuYe Dr. Lan

Role: CONTACT

Phone: +86-18520395821

Email: [email protected]

Facility Contacts

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Yawen Ms. Liang

Role: primary

Other Identifiers

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FirstAHGuangdong

Identifier Type: -

Identifier Source: org_study_id