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Diet and Prevention of Ischemic Heart Disease: a Translational Approach (DIPI)

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ClinicalTrials.gov Identifier: NCT02062424
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : June 1, 2015
Sponsor:
Collaborators:
University of Aarhus
Harvard School of Public Health
University of Copenhagen
Ministry of Food, Agriculture and Fisheries, Denmark
Information provided by (Responsible Party):
Inge Tetens, Technical University of Denmark

Brief Summary:
The objective of this study is to test the effect of substitution dietary guidelines that are specifically aimed at the prevention of ischemic heart disease (IHD) on the dietary intake in the general Danish population.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Other: DIPI Not Applicable

Detailed Description:

225 participants will be included in the intervention. The intervention is planned to run for six months in a real life setting.

The study is a randomized, parallel dietary intervention study. Dietary intake, selected IHD biomarkers and anthropometric measurements will be measured at two visits during the intervention period as well as 6 months after the end of the intervention. The study includes a baseline visit followed by a visit where web based dietary records will be completed by the subjects and blood samples and anthropometrics will be measured.

The intervention will consist of information on dietary advice due to the specific IHD dietary guideline or the current national dietary guidelines. The information will be provided to the participants via leaflets and recipes.

After the baseline visit the subjects will be randomized to group A, B or C: In group A the subjects will receive dietary advice, according to the specific IHD dietary guideline, in group B the subjects will receive dietary advice according to the current national dietary guidelines and in group C the subjects will be instructed to follow their normal dietary habits.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Diet and Prevention of Ischemic Heart Disease: a Translational Approach
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: DIPI: Danish national dietary guidelines
The subjects will receive dietary advice according to the current national dietary guidelines
Other: DIPI
Active Comparator: DIPI: Specific IHD dietary guideline
The subjects will receive dietary advice, according to the specific ischemic heart disease dietary guidelines.
Other: DIPI
No Intervention: Normal dietary habits
The Subjects will be instructed to follow their normal dietary habits



Primary Outcome Measures :
  1. Dietary intake [ Time Frame: 6 month ]
    Dietary intake will be measured at two visits during the intervention period as well as 6 months after the end of the intervention.


Secondary Outcome Measures :
  1. Selected ischemic heart disease biomarkers and anthropometric measurements [ Time Frame: 6 month ]
    Selected IHD biomarkers and anthropometric measurements will be measured at two visits during the intervention period as well as 6 months after the end of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men and women aged 30 to 65 years who has one or more self-assessed ischemic heart disease risk factors at screening: physical inactivity, overweight or obese (BMI ≥ 25/m2 ), waist circumference (≥ 80 cm for women, ≥ 94 cm for men). In addition, the participants should have the motivation and willingness to be randomized to any of the three groups, and to do their best to follow the given protocol .

Exclusion Criteria:

  • no internet access or no access to a computer, smoking, pregnancy, or breast-feeding or planning to become pregnant within the next 12 months, a history of cardiovascular disease, type 2 diabetes, chronic disease / disorders that may affect the results of the study, substance abuse within the past 12 months, regular alcohol consumption > 21 units / week for men or > 14 units/ week for women, allergy or intolerance to food groups in the dietary guidelines, supplements with mega doses of nutrients that can have potential impact on ischemic heart disease risk markers (eg . fish oils).

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): NCT02062424


Locations
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Denmark
Technical University of Denmark
Søborg, Denmark, 2860
Sponsors and Collaborators
Technical University of Denmark
University of Aarhus
Harvard School of Public Health
University of Copenhagen
Ministry of Food, Agriculture and Fisheries, Denmark
Investigators
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Principal Investigator: Inge Tetens, Professor Technical University of Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inge Tetens, Professor, Technical University of Denmark
ClinicalTrials.gov Identifier: NCT02062424     History of Changes
Other Study ID Numbers: Protocol no.:H-1-2013-110
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by Inge Tetens, Technical University of Denmark:
ischemic heart disease, dietary guidelines

Additional relevant MeSH terms:
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Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases