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

NCT01784952 | Completed DMC

• 1 other identifier: WG_APOA5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjects With Mild Hypertriglyceridemia in Type 2 DM

Outcome Measures

Primary Outcomes (1)

• Triglyceride

  change from baseline in TG at 12 weeks

Secondary Outcomes (1)

• Apolipoprotein A5

  Change from baseline in ApoA5 at 12 weeks

Other Outcomes (1)

• Apolipoprotein A5 gene

  ApoA5 -1131T>C polymorphism

Study Arms (2)

Whole grains and lequmes

EXPERIMENTAL

Dietary Supplement: Dietary intervention

refined rice

PLACEBO COMPARATOR

Dietary Supplement: Dietary intervention

Interventions

Dietary intervention DIETARY_SUPPLEMENT

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.

Whole grains and lequmes; refined rice

Eligibility Criteria

• Age: 25 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24690159 DERIVED

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Jong Ho Lee, Ph.D

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2013
• First Posted: February 6, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

KR (1)