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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Replacing With Whole Grains and Legumes Reduces Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activities in Plasma and Peripheral Blood Mononuclear Cells in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes

Conditions
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Impaired Fasting Glucose, Newly Diagnosed Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Dietary intervention-whole grains and legumes
* Dietary Supplement: Dietary intervention-Refined rice


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole grains and legumes<br> | Dietary Supplement: Dietary intervention-whole grains and legumes<br>* 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.<br>|
| Placebo Comparator: Refined rice<br> | Dietary Supplement: Dietary intervention-Refined rice<br>* Subjects in the control group maintained their usual diet of refined rice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Lp-PLA2 activity |  | Change from baseline in Lp-PLA2 at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PBMC Lp-PLA2 activity |  | Change from baseline in PBMC Lp-PLA2 at 12 weeks |