Weight Loss as Treatment in Heart Disease

University of Copenhagen30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Dietetic group sessionsBEHAVIORAL

Group sessions to improve dietary adherence

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in six minute walk test from baseline to week 16 (end of study)

Performance measure

Time frame: weeks 0 and 16

Secondary Outcomes

Change in lipid status from baseline to week 16 (end of study).

Blood sample and analyses for lipids

Time frame: weeks 0,1,2,4,6,8,10,12,14,16

Data from ClinicalTrials.gov

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