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 2

Completed

• Conditions: Type-2 Diabetes; Prediabetes
• Interventions: Dietary Supplement: Dietary intervention-refined rice; Dietary Supplement: Dietary intervention-whole grains and legumes

• Registration Number: NCT02191644
• Lead Sponsor: Yonsei University

Brief Summary

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

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 Timeline

• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• subjects who had IFG (100≤ fasting glucose <126 mg/dL)
• or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Refined rice	Dietary intervention-refined rice	-
Whole grains and legumes	Dietary intervention-whole grains and legumes	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PBMC metabolites	Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of