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
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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