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
Sponsored by
About this trial
This is an interventional basic science trial for Prediabetes
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
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
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
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
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
No
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
Learn more about this trial
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
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