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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Prediabetes; Type-2 Diabetes

Treatments: Dietary Supplement: Dietary intervention-whole grains and legumes; Dietary Supplement: Dietary intervention-refined rice

Study type: Interventional

Funder types: Other

Identifiers

NCT02191644

PBMC_Lp-PLA2_metabolite

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 82 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups, including a placebo group

Refined rice

Placebo Comparator group

Treatment:

Dietary Supplement: Dietary intervention-refined rice

Whole grains and legumes

Experimental group

Treatment:

Dietary Supplement: Dietary intervention-whole grains and legumes