Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes

NCT07289880 | Not Yet Recruiting

• 1 other identifier: FirstAHGuangdong
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prediabetes

Outcome Measures

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.

  up to 4 weeks

Secondary Outcomes (8)

• weight

  up to 4 weeks

• fasting blood glucose

  At baseline and after 4 weeks of intervention

• lipid metabolism

  At baseline and after 4 weeks of intervention

• HbA1c

  At baseline and after 4 weeks of intervention

• intestinal bacteria

  up to 4 weeks

Study Arms (2)

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.

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.

Combination Product: Colza Oil

Interventions

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.

DAG Oil Group

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.

Control Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangdong Pharmaceutical University: lead

Study Sites (1)

Beijing Street

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Diglycerides

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glycerides; Lipids

Central Study Contacts

QiuYe Dr. Lan

CONTACT

+86-18520395821; lanqiuye@gdpu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)