Back to resultsConsumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant
Primary Purpose
Subjects With Mild Hypertriglyceridemia in Type 2 DM
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional basic science trial for Subjects With Mild Hypertriglyceridemia in Type 2 DM
Eligibility Criteria
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
Sites / Locations
- Yonsei university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Whole grains and lequmes
refined rice
Arm Description
Outcomes
Primary Outcome Measures
Triglyceride
Secondary Outcome Measures
Apolipoprotein A5
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01784952
Brief Title
Consumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects With Mild Hypertriglyceridemia in Type 2 DM
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole grains and lequmes
Arm Type
Experimental
Arm Title
refined rice
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Triglyceride
Time Frame
change from baseline in TG at 12 weeks
Secondary Outcome Measure Information:
Title
Apolipoprotein A5
Time Frame
Change from baseline in ApoA5 at 12 weeks
Other Pre-specified Outcome Measures:
Title
Apolipoprotein A5 gene
Time Frame
ApoA5 -1131T>C polymorphism
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Lee, Ph.D
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei university
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24690159
Citation
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.
Results Reference
derived
Learn more about this trial
Consumption of Whole Grains and Legumes Modulates the Genetic Effect of the APOA5 -1131C Variant
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