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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02191644
First Posted: July 16, 2014
Last Update Posted: July 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • Lp-PLA2 Activity in PBMC [ Time Frame: Change from baseline in Lp-PLA2 at 12 weeks ]

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

Other Outcome Measures:
  • LDL particle size [ Time Frame: Changes from baseline in LDL particle size at 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02191644     History of Changes
Other Study ID Numbers: PBMC_Lp-PLA2_metabolite
First Submitted: July 14, 2014
First Posted: July 16, 2014
Last Update Posted: July 16, 2014
Last Verified: July 2014

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