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Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02062424
Acronym
DIPI
Enrollment
222
Registered
2014-02-13
Start date
2014-02-28
Completion date
2015-05-31
Last updated
2015-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

ischemic heart disease, dietary guidelines

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.

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.

Interventions

OTHERDIPI

Sponsors

University of Aarhus
CollaboratorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
Ministry of Food, Agriculture and Fisheries, Denmark
CollaboratorUNKNOWN
Technical University of Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Dietary intake6 monthDietary intake will be measured at two visits during the intervention period as well as 6 months after the end of the intervention.

Secondary

MeasureTime frameDescription
Selected ischemic heart disease biomarkers and anthropometric measurements6 monthSelected 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026