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Not yet recruiting NCT07289880

Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes

No phase Interventional Prediabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diacylglycerol oil, Colza Oil.
Who it may be relevant to
Registry conditions: Prediabetes. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Continuous Glucose Monitoring (CGM) Data [Time frame: up to 4 weeks]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Beijing Street — Guangzhou

Identifiers

NCT: NCT07289880 · FirstAHGuangdong

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗