Can a Modified Fat Diet With Low Glycaemic Load Improve Insulin Sensitivity and Inflammatory Mediators in Overweight People With Chronic Heart Failure?

NCT00163904 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2007-08-01

No results posted yet for this study

Summary

This study is looking at overweight patients with chronic heart failure (CHF), to compare the effects of a modified fat diet with a reduced glycaemic load (diet 1); and a conventional low fat, high carbohydrate diet (diet 2) on:

* insulin sensitivity (using the homeostasis model assessment \[HOMA\] model)
* lipid profile
* symptomatic status (6 minute walk distance and Heart Failure Quality of Life \[HF QOL\] Questionnaire)
* body weight
* inflammatory mediators (tumor necrosis factor \[TNF\] alpha, C-reactive protein \[CRP\], interleukin-6 \[IL-6\])

The hypotheses of this study are:

* Diet 1 will be associated with lower insulin resistance than diet 2.
* The lipid profile will be better in CHF patients on diet 1 than on diet 2.
* Patients on diet 1 will have a better symptomatic status than patients on diet 2.
* Diet 1 will maintain body weight in patients with CHF as well as diet 2.
* Diet 1 will suppress the expression of TNF-alpha, CRP and IL-6 more than diet 2.

Conditions

Interventions

BEHAVIORAL

High mono-unsaturated fat/low carbohydrate diet

BEHAVIORAL

High carbohydrate/low fat diet

Sponsors & Collaborators

  • Bayside Health

    lead OTHER_GOV

Principal Investigators

  • Fiona J Adams, BSc. Grad Dip Diet · Dietition on Staff, Alfred Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00163904 on ClinicalTrials.gov