Dietary Intervention Replacing Carbohydrate With Protein... | NCT02191644

Studies
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

NCT02191644

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

82Actual

Phase

Phase 2

Conditions

Prediabetes
Type-2 Diabetes

Interventions

Dietary intervention-refined rice
Dietary intervention-whole grains and legumes

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Jul 15, 2014

First Posted Date

Jul 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2014

Last Update Posted Date

Jul 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Refined rice	Placebo Comparator		Dietary Supplement: Dietary intervention-refined rice
Whole grains and legumes	Experimental		Dietary Supplement: Dietary intervention-whole grains and legumes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary intervention-refined rice	Dietary Supplement	Subjects in the control group maintained the usual refined-rice diet.	Refined rice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
PBMC metabolites		Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)

Other Outcomes

Measure	Description	Time Frame
LDL particle size		Changes from baseline in LDL particle size at 12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jong Ho Lee, PhD	Yonsei University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University		Seoul		120-749	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26788114	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases