Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Other: DIPI


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake | Dietary intake will be measured at two visits during the intervention period as well as 6 months after the end of the intervention. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selected ischemic heart disease biomarkers and anthropometric measurements | 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. | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic heart disease, dietary guidelines