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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784952
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : February 6, 2013
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE February 3, 2013
First Posted Date  ICMJE February 6, 2013
Last Update Posted Date February 6, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
Triglyceride [ Time Frame: change from baseline in TG at 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
Apolipoprotein A5 [ Time Frame: Change from baseline in ApoA5 at 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 5, 2013)
Apolipoprotein A5 gene [ Time Frame: ApoA5 -1131T>C polymorphism ]
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Consumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant
Official Title  ICMJE Not Provided
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Subjects With Mild Hypertriglyceridemia in Type 2 DM
Intervention  ICMJE Dietary Supplement: Dietary 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.
Study Arms  ICMJE
  • Experimental: Whole grains and lequmes
    Intervention: Dietary Supplement: Dietary intervention
  • Placebo Comparator: refined rice
    Intervention: Dietary Supplement: Dietary intervention
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2013)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01784952
Other Study ID Numbers  ICMJE WG_APOA5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jong Ho Lee, Ph.D Yonsei University
PRS Account Yonsei University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP