NCT01895387

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

June 14, 2013

Last Update Submit

July 4, 2013

Conditions

Impaired Fasting GlucoseNewly Diagnosed Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Plasma Lp-PLA2 activity

    Change from baseline in Lp-PLA2 at 12 weeks

Secondary Outcomes (1)

  • PBMC Lp-PLA2 activity

    Change from baseline in PBMC Lp-PLA2 at 12 weeks

Other Outcomes (1)

  • LDL particle size

    Change from baseline in LDL particle size at 12 weeks

Study Arms (2)

Whole grains and legumes

EXPERIMENTAL
Dietary Supplement: Dietary intervention-whole grains and legumes

Refined rice

PLACEBO COMPARATOR
Dietary Supplement: Dietary intervention-Refined rice

Interventions

Dietary intervention-whole grains and legumesDIETARY_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.

Whole grains and legumes
Dietary intervention-Refined riceDIETARY_SUPPLEMENT

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

Refined rice

Eligibility Criteria

Age39 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University

Seoul, South Korea

Location

Study Officials

  • Jong Ho Lee, Ph.D

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

July 10, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations

KR(1)