Ischemic Heart Disease Clinical Trial
— DIPIOfficial title:
Diet and Prevention of Ischemic Heart Disease: a Translational Approach
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.
Status | Completed |
Enrollment | 222 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 65 Years |
Eligibility |
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). |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Technical University of Denmark | Søborg |
Lead Sponsor | Collaborator |
---|---|
Technical University of Denmark | Harvard School of Public Health, Ministry of Food, Agriculture and Fisheries, Denmark, University of Aarhus, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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