Weight Loss as Treatment in Heart Disease
Not Applicable
Completed
- Conditions
- Heart Failure
- Interventions
- Behavioral: Dietetic group sessions
- Registration Number
- NCT02105805
- Lead Sponsor
- University of Copenhagen
- Brief Summary
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- bmi >30
- 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
- unstable disease
- insulin treated diabetes
- pregnancy or lactating
- unstable weight past 6 months (+- 10 kg)
- planned procedures in the time of intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low energy diet Dietetic group sessions low energy diet treatment Nordic recommendation Dietetic group sessions Nordic recommendation, no restrictions on energy
- Primary Outcome Measures
Name Time Method Change in six minute walk test from baseline to week 16 (end of study) weeks 0 and 16 Performance measure
- Secondary Outcome Measures
Name Time Method Change in lipid status from baseline to week 16 (end of study). weeks 0,1,2,4,6,8,10,12,14,16 Blood sample and analyses for lipids