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CompletedNCT01784952Updated Feb 6, 2013

Consumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant

An interventional study of Dietary intervention in Subjects With Mild Hypertriglyceridemia in Type 2 DM, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 25 Years to 72 Years. Per ClinicalTrials.gov, last updated 2013-02-06.

Sponsored by Yonsei University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
25 Years to 72 Years
Sex
All
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Study summary

We examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of this variant on changes in apolipoprotein A-V (apoA-V) and triglyceride concentrations.

Read the detailed description

We genotyped the APOA5 -1131T>C in individuals with impaired fasting glucose (IFG) or newly diagnosed type 2 diabetes, who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12 weeks.

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Conditions studied

  • Subjects With Mild Hypertriglyceridemia in Type 2 DM

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03

In context

Hypertriglyceridemia

296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.

This study's enrollment of 200 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects who were in in impaired fasting glucose (IFG, 100≤ fasting glucose \<126 mg/dL) and newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dL) were referred to the Department of Family Medicine or Internal Medicine. They were rechecked for their health and lipid profiles, and then those who satisfied the study criteria were recommended to participate in the dietary intervention program

Exclusion criteria

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 6months
  • Pregnancy or lactation. Subjects who were taking medication were also excluded
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Whole grains and lequmes

    Dietary Supplement: Dietary intervention

  • Placebo comparator
    refined rice

    Dietary Supplement: Dietary intervention

Interventions

  • Dietary supplementDietary intervention

    The intervention program consisted of replacing of refined rice intake with 1/3 of legumes, 1/3 of barleys, and 1/3 of whole grains three times per day as a high carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake. The subjects were recommended to drink no more than one alcoholic beverage drink (15 g alcohol) per day and were assigned physical activity consisting of a regular 30-min walk after dinner each day. Participants were also instructed to record their physical activity diary for 24 h every 4 weeks.

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What researchers measure

Primary outcomes

  1. Triglyceride

    Time frame: change from baseline in TG at 12 weeks

Secondary outcomes

  1. Apolipoprotein A5

    Time frame: Change from baseline in ApoA5 at 12 weeks

Other outcomes

  1. Apolipoprotein A5 gene

    Time frame: ApoA5 -1131T>C polymorphism

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Study locations

1 site
  • Yonsei university
    Seoul, Korea, Republic of
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References and documents

Publications

  • Kang R, Kim M, Chae JS, Lee SH, Lee JH. Consumption of whole grains and legumes modulates the genetic effect of the APOA5 -1131C variant on changes in triglyceride and apolipoprotein A-V concentrations in patients with impaired fasting glucose or newly diagnosed type 2 diabetes. Trials. 2014 Apr 1;15:100. doi: 10.1186/1745-6215-15-100. PubMed 24690159 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01784952
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Feb 6, 2013
Start date
Jan 2012
Primary completion
Jun 2012
Completion
Oct 2012
Last update
Feb 6, 2013

Study contacts

Jong Ho Lee, Ph.D
principal investigator · Yonsei University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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