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

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Yonsei University

Status

Completed

Conditions

Subjects With Mild Hypertriglyceridemia in Type 2 DM

Treatments

Dietary Supplement: Dietary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01784952
WG_APOA5

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

All

Ages

25 to 72 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups, including a placebo group

Whole grains and lequmes
Experimental group
Treatment:
Dietary Supplement: Dietary intervention
refined rice
Placebo Comparator group
Treatment:
Dietary Supplement: Dietary intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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