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CompletedNCT01895387Updated Jul 10, 2013

Dietary Effects on Circulating Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity and Enzyme Activity in Peripheral Blood Mononuclear Cells (PBMCs) in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes

An interventional study of Dietary intervention-whole grains and legumes and Dietary intervention-Refined rice in Impaired Fasting Glucose and Newly Diagnosed Type 2 Diabetes, sponsored by Yonsei University. Completed at 1 site in South Korea. Open to participants aged 39 Years to 74 Years. Per ClinicalTrials.gov, last updated 2013-07-10.

Sponsored by Yonsei University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
39 Years to 74 Years
Sex
All
01

Study summary

We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.

Read the detailed description

Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.

02

Conditions studied

  • Impaired Fasting Glucose
  • Newly Diagnosed Type 2 Diabetes
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
39 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose \<126 mg/dL)
  • or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL)

Exclusion criteria

Exclusion Criteria:

  • current and/or past history of cardiovascular disease including angina
  • liver or kidney dysfunction
  • thyroid or pituitary disease
  • unstable weight loss/gain (≥2 kg) over the previous 12 months
  • pregnancy or lactation
  • taking medications or supplements
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Whole grains and legumes

    Dietary Supplement: Dietary intervention-whole grains and legumes

  • Placebo comparator
    Refined rice

    Dietary Supplement: Dietary intervention-Refined rice

Interventions

  • Dietary supplementDietary intervention-whole grains and legumes

    Subjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.

  • Dietary supplementDietary intervention-Refined rice

    Subjects in the control group maintained their usual diet of refined rice

06

What researchers measure

Primary outcomes

  1. Plasma Lp-PLA2 activity

    Time frame: Change from baseline in Lp-PLA2 at 12 weeks

Secondary outcomes

  1. PBMC Lp-PLA2 activity

    Time frame: Change from baseline in PBMC Lp-PLA2 at 12 weeks

Other outcomes

  1. LDL particle size

    Time frame: Change from baseline in LDL particle size at 12 weeks

07

Study locations

1 site
  • Yonsei University
    Seoul, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01895387
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 10, 2013
Start date
Jan 2012
Primary completion
Jun 2012
Completion
Oct 2012
Last update
Jul 10, 2013

Study contacts

Jong Ho Lee, Ph.D
principal investigator · Yonsei University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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