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

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.

Study Overview

• Status: Completed
• Conditions: Subjects With Mild Hypertriglyceridemia in Type 2 DM
• Intervention / Treatment: Dietary supplement: Dietary intervention

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: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole grains and lequmes	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.
Placebo Comparator: refined rice	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Triglyceride	change from baseline in TG at 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Apolipoprotein A5	Change from baseline in ApoA5 at 12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Apolipoprotein A5 gene	ApoA5 -1131T>C polymorphism

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 3, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 6, 2013

Study Record Updates

• Last Update Posted (Estimate): February 6, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: WG_APOA5