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

Not Applicable

Completed

• Conditions: Subjects With Mild Hypertriglyceridemia in Type 2 DM
• Interventions: Dietary Supplement: Dietary intervention

• Registration Number: NCT01784952
• Lead Sponsor: Yonsei University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2013-02
• Study First Submitted: 2013-02-03
• Study First Submitted QC: 2013-02-05
• Last Update Submitted: 2013-02-05
• Study First Posted: 2013-02-06
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole grains and lequmes	Dietary intervention	-
refined rice	Dietary intervention	-

Primary Outcome Measures

Name	Time	Method
Triglyceride	change from baseline in TG at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Apolipoprotein A5	Change from baseline in ApoA5 at 12 weeks

Trial Locations

Locations (1)

Yonsei university; 🇰🇷 Seoul, Korea, Republic of