Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Ischemic Heart Disease Clinical Trial

— DIPI  

Official title:

Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062424
• Other study ID #: Protocol no.:H-1-2013-110
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: May 29, 2015
• Start date: February 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Technical University of Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• DIPI

Locations

Country	Name	City	State
Denmark	Technical University of Denmark	Søborg

Sponsors (5)

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

Country where clinical trial is conducted

Denmark, 

Outcome

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