Dietary Effects on Circulating Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity and Enzyme Activity in Peripheral Blood Mononuclear Cells (PBMCs) in Patients With Prediabetes or Newly Diagnosed Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

Brief Summary

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We determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating Lp-PLA2 activity and enzyme activity in peripheral blood mononuclear cells (PBMCs) in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes.

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Detailed Description

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Ninety-nine patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.

Conditions

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Impaired Fasting Glucose Newly Diagnosed Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Whole grains and legumes

Group Type EXPERIMENTAL

Dietary intervention-whole grains and legumes

Intervention Type DIETARY_SUPPLEMENT

Subjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.

Refined rice

Group Type PLACEBO_COMPARATOR

Dietary intervention-Refined rice

Intervention Type DIETARY_SUPPLEMENT

Subjects in the control group maintained their usual diet of refined rice

Interventions

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Dietary intervention-whole grains and legumes

Subjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.

Intervention Type DIETARY_SUPPLEMENT

Dietary intervention-Refined rice

Subjects in the control group maintained their usual diet of refined rice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Subjects who were in in impaired fasting glucose (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
* unstable weight loss/gain (≥2 kg) over the previous 12 months
* pregnancy or lactation
* taking medications or supplements

Minimum Eligible Age

39 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No