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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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02191644
Enrollment
82
Registered
2014-07-16
Start date
2013-01-31
Completion date
2013-06-30
Last updated
2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes, Type-2 Diabetes

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.

Interventions

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

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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Lp-PLA2 Activity in PlasmaChange from baseline in Lp-PLA2 at 12 weeks
Lp-PLA2 Activity in PBMCChange from baseline in Lp-PLA2 at 12 weeks

Secondary

MeasureTime frame
PBMC metabolitesChange in L-leucine, oleamide, lysoPC (16:0), and lysoPC (18:0)

Other

MeasureTime frame
LDL particle sizeChanges from baseline in LDL particle size at 12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026