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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

Primary Purpose

Prediabetes, Type-2 Diabetes

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Dietary intervention-refined rice

Dietary intervention-whole grains and legumes

About this trial

This is an interventional basic science trial for Prediabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Refined rice

Whole grains and legumes

Arm Description

Outcomes

Primary Outcome Measures

Lp-PLA2 Activity in Plasma

Lp-PLA2 Activity in PBMC

Secondary Outcome Measures

PBMC metabolites

Full Information

NCT ID

NCT02191644

First Posted

July 14, 2014

Last Updated

July 15, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02191644

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes, Type-2 Diabetes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Refined rice

Arm Type

Placebo Comparator

Arm Title

Whole grains and legumes

Arm Type

Experimental

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary intervention-refined rice

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary intervention-whole grains and legumes

Intervention Description

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.

Primary Outcome Measure Information:

Title

Lp-PLA2 Activity in Plasma

Time Frame

Change from baseline in Lp-PLA2 at 12 weeks

Title

Lp-PLA2 Activity in PBMC

Time Frame

Change from baseline in Lp-PLA2 at 12 weeks

Secondary Outcome Measure Information:

Title

PBMC metabolites

Time Frame

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

Other Pre-specified Outcome Measures:

Title

LDL particle size

Time Frame

Changes from baseline in LDL particle size at 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong Ho Lee, PhD

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yonsei University

City

Seoul

ZIP/Postal Code

120-749

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26788114

Citation

Kim M, Song G, Kang M, Yoo HJ, Jeong TS, Lee SH, Lee JH. Replacing carbohydrate with protein and fat in prediabetes or type-2 diabetes: greater effect on metabolites in PBMC than plasma. Nutr Metab (Lond). 2016 Jan 19;13:3. doi: 10.1186/s12986-016-0063-4. eCollection 2016.

Results Reference

derived

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