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OpenTrials
Completed

NCT Number: NCT02191644

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 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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State Type-2 Diabetes

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yonsei University

Seoul, 120-749, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary intervention-refined rice

Dietary Supplement

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

Dietary intervention-whole grains and legumes

Dietary Supplement

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 outcomes

  1. Lp-PLA2 Activity in Plasma

    Time frame: Change from baseline in Lp-PLA2 at 12 weeks

  2. Lp-PLA2 Activity in PBMC

    Time frame: Change from baseline in Lp-PLA2 at 12 weeks

Secondary outcomes

  1. PBMC metabolites

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

Other outcomes

  1. LDL particle size

    Time frame: Changes from baseline in LDL particle size at 12 weeks

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 16, 2014
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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