Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes

Study Overview
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Brief Summary
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This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma.

Detailed Description
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Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2 diabetes were randomly assigned to a control group (normal diet with refined rice) or a whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4% of protein-derived energy and approximately 3% of fat-derived energy.

Official Title
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Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes

Conditions
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Prediabetes, Type-2 Diabetes

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects who had 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 pregnancy or lactation taking medications or supplements

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| Placebo Comparator: Refined rice<br> | Dietary Supplement: Dietary intervention-refined rice<br>* Subjects in the control group maintained the usual refined-rice diet.<br>|
| Experimental: Whole grains and legumes<br> | Dietary Supplement: Dietary intervention-whole grains and legumes<br>* Subjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PBMC metabolites |  | Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0) |