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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prediabetes
• Intervention / Treatment: Combination product: Diacylglycerol oil; Combination product: Colza Oil

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: QiuYe Dr. Lan; Phone Number: +86-18520395821; Email: lanqiuye@gdpu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Beijing Street
      • Contact: Yawen Ms. Liang; Phone Number: +86-18718707135; Email: lyaw0401@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Glucose Monitoring (CGM) Data	At baseline, and 4 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants.	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	At baseline, and 4 weeks, investigators will examine weight.	up to 4 weeks
fasting blood glucose	At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine fasting blood glucose.	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.	At baseline and after 4 weeks of intervention
HbA1c	At baseline, and 4 weeks, investigators will use automatic electrochemiluminescence analyzer to examine HbA1c.	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.	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.	At baseline and after 4 weeks of intervention
blood pressure	At baseline, and 4 weeks, investigators will test the systolic blood pressure and diastolic blood pressure using automatic digital blood pressure monitor.	up to 4 weeks
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.	up to 4 weeks

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangdong Pharmaceutical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Estimated): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Prediabetic State; Lipids; Glycerides; Diglycerides
• Other Study ID Numbers: FirstAHGuangdong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No