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

Primary Purpose

Ischemic Heart Disease

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

DIPI

About this trial

This is an interventional prevention trial for Ischemic Heart Disease focused on measuring ischemic heart disease, dietary guidelines

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Technical University of Denmark

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

DIPI: Danish national dietary guidelines

DIPI: Specific IHD dietary guideline

Normal dietary habits

Arm Description

The subjects will receive dietary advice according to the current national dietary guidelines

The subjects will receive dietary advice, according to the specific ischemic heart disease dietary guidelines.

The Subjects will be instructed to follow their normal dietary habits

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02062424

First Posted

February 12, 2014

Last Updated

May 29, 2015

Sponsor

Technical University of Denmark

Collaborators

University of Aarhus, Harvard School of Public Health (HSPH), University of Copenhagen, Ministry of Food, Agriculture and Fisheries, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02062424

Brief Title

Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Acronym

DIPI

Official Title

Diet and Prevention of Ischemic Heart Disease: a Translational Approach

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Technical University of Denmark

Collaborators

University of Aarhus, Harvard School of Public Health (HSPH), University of Copenhagen, Ministry of Food, Agriculture and Fisheries, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

ischemic heart disease, dietary guidelines

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

222 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DIPI: Danish national dietary guidelines

Arm Type

Active Comparator

Arm Description

The subjects will receive dietary advice according to the current national dietary guidelines

Arm Title

DIPI: Specific IHD dietary guideline

Arm Type

Active Comparator

Arm Description

The subjects will receive dietary advice, according to the specific ischemic heart disease dietary guidelines.

Arm Title

Normal dietary habits

Arm Type

No Intervention

Arm Description

The Subjects will be instructed to follow their normal dietary habits

Intervention Type

Other

Intervention Name(s)

DIPI

Primary Outcome Measure Information:

Title

Dietary intake

Description

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

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Selected ischemic heart disease biomarkers and anthropometric measurements

Description

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.

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Inge Tetens, Professor

Organizational Affiliation

Technical University of Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Technical University of Denmark

City

Søborg

ZIP/Postal Code

2860

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

32827219

Citation

Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3.

Results Reference

derived

PubMed Identifier

32428300

Citation

Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2.

Results Reference

derived

PubMed Identifier

29352831

Citation

Arentoft JL, Hoppe C, Andersen EW, Overvad K, Tetens I. Associations between adherence to the Danish Food-Based Dietary Guidelines and cardiometabolic risk factors in a Danish adult population: the DIPI study. Br J Nutr. 2018 Mar;119(6):664-673. doi: 10.1017/S0007114517003695. Epub 2018 Jan 21.

Results Reference

derived

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Diet and Prevention of Ischemic Heart Disease: a Translational Approach

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