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
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Heart Disease focused on measuring ischemic heart disease, dietary guidelines
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).
Sites / Locations
- Technical University of Denmark
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
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
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
Learn more about this trial
Diet and Prevention of Ischemic Heart Disease: a Translational Approach
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