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

Phase 2CompletedNCT02191644

Yonsei University82 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Prediabetes Type-2 Diabetes

Interventions

Dietary intervention-refined riceDIETARY_SUPPLEMENT

Subjects in the control group maintained the usual refined-rice diet.

Dietary intervention-whole grains and legumesDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Yonsei University

Seoul, South Korea

Outcomes

Primary Outcomes

Lp-PLA2 Activity in Plasma

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

Lp-PLA2 Activity in PBMC

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

Secondary Outcomes

PBMC metabolites

Time frame: Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)

Data from ClinicalTrials.gov

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