Ischemic Heart DiseaseDIPINCT02062424
Diet and Prevention of Ischemic Heart Disease: a Translational Approach
A study testing DIPI in people with Ischemic Heart Disease, run by Technical University of Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- DIPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- DIPI
- Keywords
- ischemic heart disease, dietary guidelines
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIPIOther
| Study group | Role | What they receive |
|---|---|---|
| DIPI: Danish national dietary guidelines | Active comparator | The subjects will receive dietary advice according to the current national dietary guidelines Receives: Other: DIPI |
| DIPI: Specific IHD dietary guideline | Active comparator | The subjects will receive dietary advice, according to the specific ischemic heart disease dietary guidelines. Receives: Other: DIPI |
| Normal dietary habits | No intervention | The Subjects will be instructed to follow their normal dietary habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (1)
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Harvard School of Public Health (HSPH), University of Copenhagen, Ministry of Food, Agriculture and Fisheries, Denmark
- Responsible party
- Principal investigator, Inge Tetens, Technical University of Denmark
- Investigators
- Inge Tetens, Professor, Principal investigator, Technical University of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062424
- Sponsor's protocol ID
- Protocol no.:H-1-2013-110
- Acronym
- DIPI
- Status last verified
- May 2015
- First submitted
- 12 Feb 2014
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32827219Hooper 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.
PubMed 32428300Arentoft 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.
PubMed 29352831
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Prevention of Ischemic Heart Disease: a Translational Approach
- ClinicalTrials.gov ID
- NCT02062424
- Acronym / sponsor ID
- DIPI / Protocol no.:H-1-2013-110
- Conditions
- Ischemic Heart Disease
- Keywords
- ischemic heart disease, dietary guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Technical University of DenmarkUniversity, hospital or other
- Collaborators
- University of Aarhus, Harvard School of Public Health (HSPH), University of Copenhagen, Ministry of Food, Agriculture and Fisheries, Denmark
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DIPI: Danish national dietary guidelines | Active comparator | Other: DIPIThe subjects will receive dietary advice according to the current national dietary guidelines |
| DIPI: Specific IHD dietary guideline | Active comparator | Other: DIPIThe subjects will receive dietary advice, according to the specific ischemic heart disease dietary guidelines. |
| Normal dietary habits | No intervention | –The Subjects will be instructed to follow their normal dietary habits |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIPI | Other | DIPI: Danish national dietary guidelines, DIPI: Specific IHD dietary guideline |
Primary outcome
Dietary intake
Time frame: 6 month
Dietary intake will be measured at two visits during the intervention period as well as 6 months after the end of the intervention.
1 secondary outcome
Selected ischemic heart disease biomarkers and anthropometric measurements
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Derived from this study: PubMed 32827219Hooper 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.
- Derived from this study: PubMed 32428300Hooper 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.
- Derived from this study: PubMed 29352831Arentoft 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inge Tetens, Professor principal investigator
Technical University of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIPI in people with Ischemic Heart Disease, run by Technical University of Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary intake (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062424, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2015.