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

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ClinicalTrials.gov Identifier: NCT01784952
Recruitment Status : Completed
First Posted : February 6, 2013
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Subjects With Mild Hypertriglyceridemia in Type 2 DM Dietary Supplement: Dietary intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

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.




Primary Outcome Measures :
  1. Triglyceride [ Time Frame: change from baseline in TG at 12 weeks ]

Secondary Outcome Measures :
  1. Apolipoprotein A5 [ Time Frame: Change from baseline in ApoA5 at 12 weeks ]

Other Outcome Measures:
  1. Apolipoprotein A5 gene [ Time Frame: ApoA5 -1131T>C polymorphism ]


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Ages Eligible for Study:   25 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784952


Locations
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Korea, Republic of
Yonsei university
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jong Ho Lee, Ph.D Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01784952     History of Changes
Other Study ID Numbers: WG_APOA5
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases