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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT02191644
First received: July 14, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Prediabetes
Type-2 Diabetes
Dietary Supplement: Dietary intervention-refined rice
Dietary Supplement: Dietary intervention-whole grains and legumes
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Lp-PLA2 Activity in Plasma [ Time Frame: Change from baseline in Lp-PLA2 at 12 weeks ] [ Designated as safety issue: Yes ]
  • Lp-PLA2 Activity in PBMC [ Time Frame: Change from baseline in Lp-PLA2 at 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PBMC metabolites [ Time Frame: Change in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0) ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • LDL particle size [ Time Frame: Changes from baseline in LDL particle size at 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Refined rice Dietary Supplement: Dietary intervention-refined rice
Subjects in the control group maintained the usual refined-rice diet.
Experimental: Whole grains and legumes Dietary Supplement: 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02191644

Locations
Korea, Republic of
Yonsei University
Seoul, Korea, Republic of, 120-749
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Jong Ho Lee, PhD Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02191644     History of Changes
Other Study ID Numbers: PBMC_Lp-PLA2_metabolite
Study First Received: July 14, 2014
Last Updated: July 15, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on October 16, 2014