Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2010-10-31
2011-08-31
Brief Summary
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All will receive dietetic advice according to randomization and according to the European Heart Association.
Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.
Control subjects are advised to follow the Nordic Nutrition Recommendations.
Patients will be monitored by blood sampling and assessed by change in physical performance.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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low energy diet
low energy diet treatment
Dietetic group sessions
Group sessions to improve dietary adherence
Nordic recommendation
Nordic recommendation, no restrictions on energy
Dietetic group sessions
Group sessions to improve dietary adherence
Interventions
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Dietetic group sessions
Group sessions to improve dietary adherence
Eligibility Criteria
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Inclusion Criteria
* heart failure, moderate to severe, new york heart association II og III
* stable disease
* age \>18 years
* out-patients
* perform a six minutes walk test
* given consent
Exclusion Criteria
* insulin treated diabetes
* pregnancy or lactating
* unstable weight past 6 months (+- 10 kg)
* planned procedures in the time of intervention
18 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
University of Copenhagen
OTHER
Responsible Party
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Arne Astrup
Professor
Other Identifiers
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GEN-01-clinnutr
Identifier Type: -
Identifier Source: org_study_id
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