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

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191644
• Other study ID #: PBMC_Lp-PLA2_metabolite
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2014
• Last updated: July 15, 2014
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Prediabetes
• Prediabetic State
• Type-2 Diabetes

Intervention

Dietary Supplement:
• Dietary intervention-refined rice
Subjects in the control group maintained the usual refined-rice diet.
• Dietary intervention-whole grains and legumes
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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LDL particle size		Changes from baseline in LDL particle size at 12 weeks	Yes
Primary	Lp-PLA2 Activity in Plasma		Change from baseline in Lp-PLA2 at 12 weeks	Yes
Primary	Lp-PLA2 Activity in PBMC		Change from baseline in Lp-PLA2 at 12 weeks	Yes
Secondary	PBMC metabolites		Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)	Yes