Weight Loss as Treatment in Heart Disease

University of Copenhagen

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Dietetic group sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT02105805

GEN-01-clinnutr

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

low energy diet

Experimental group

Description:

low energy diet treatment

Treatment:

Behavioral: Dietetic group sessions

Nordic recommendation

Active Comparator group

Description:

Nordic recommendation, no restrictions on energy

Treatment:

Behavioral: Dietetic group sessions