NCT02062424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

February 12, 2014

Last Update Submit

May 29, 2015

Conditions

Ischemic Heart Disease

Keywords

ischemic heart disease, dietary guidelines

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Selected ischemic heart disease biomarkers and anthropometric measurements

    6 month

Study Arms (3)

DIPI: Danish national dietary guidelines

ACTIVE COMPARATOR

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

Other: DIPI

DIPI: Specific IHD dietary guideline

ACTIVE COMPARATOR

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

Other: DIPI

Normal dietary habits

NO INTERVENTION

The Subjects will be instructed to follow their normal dietary habits

Interventions

DIPIOTHER
DIPI: Danish national dietary guidelinesDIPI: Specific IHD dietary guideline

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University of Denmark

Søborg, Denmark, 2860, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 32827219DERIVED

  • 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.

    PMID: 32428300DERIVED

  • 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.

    PMID: 29352831DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

4',6-bis(2'imidazolinyl-4',5'-H)-2-phenylindole

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Inge Tetens, Professor

    Technical University of Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 13, 2014

Study Start

February 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

DK(1)