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

Subjects With Mild Hypertriglyceridemia in Type 2 DM Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784952
• Other study ID #: WG_APOA5
• Status: Completed
• Phase: N/A
• First received: February 3, 2013
• Last updated: February 5, 2013
• Start date: January 2012
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 72 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Subjects With Mild Hypertriglyceridemia in Type 2 DM

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei university	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apolipoprotein A5 gene		ApoA5 -1131T>C polymorphism	Yes
Primary	Triglyceride		change from baseline in TG at 12 weeks	Yes
Secondary	Apolipoprotein A5		Change from baseline in ApoA5 at 12 weeks	Yes