Can a Modified Fat Diet With Low Glycaemic Load Improve Insulin Sensitivity and Inflammatory Mediators in Overweight People With Chronic Heart Failure?
NCT ID: NCT00163904
Last Updated: 2007-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2005-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The introduction of beta-blockers in the treatment of CHF may have a beneficial effect on insulin resistance. However, so far tested drugs seem to have little influence on production of pro-inflammatory markers in CHF patients. The use of beta-blockers in the clinical setting is also associated with weight gain. While weight gain is of benefit to patients with cachexia, a common problem in CHF, it is problematic in CHF patients who are already overweight, particularly since obesity is known to be implicated in the development of insulin resistance. Because of this, it would seem to be beneficial to prevent further weight gain in those patients with heart failure who are not cachexic. Weight loss in these patients, however should also be prevented since obese patients with CHF appear to have the better prognosis. As change in body weight has important implications for disease progression, choice of dietary treatment is of particular importance in CHF patients. Ideally in CHF patients, we should be maintaining body weight while still attempting to reduce other coronary risk factors such as insulin resistance and atherogenic dyslipidemia.
Traditionally, diet for people with insulin resistance and other features of the metabolic syndrome has been based on a low fat, high carbohydrate dietary prescription. This has been questioned recently with emerging clear endorsement of diets that are restricted in saturated fat (\< 10% of total energy \[%E\]) but by allowing higher amounts of monounsaturated fat (MUFA), also reduce the diet carbohydrate content and thus the glycaemic load. Metabolic studies in people with diabetes have shown that modified fat (high MUFA) diets are more effective than a low fat high carbohydrate diet in improving insulin resistance although no similar studies are yet available for people with heart failure.
Studies in people with diabetes have also indicated that modified fat (high MUFA) diets are clearly more beneficial than low fat diets in the effects on triacylglycerols and HDL cholesterol and they also favorably influence blood pressure, coagulation, endothelial activation, inflammation, and thermogenic capacity. Modified fat (high MUFA) diets therefore reduce heart disease risk. Moreover, when the energy density is controlled through inclusion of plenty of fruit and vegetables, modified fat (high MUFA) diets do not promote obesity. One final benefit is better acceptance and compliance long term.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
High mono-unsaturated fat/low carbohydrate diet
High carbohydrate/low fat diet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients with heart failure NYHA Class 4 will be excluded due to their increased risk of developing cachexia.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayside Health
OTHER_GOV
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fiona J Adams, BSc. Grad Dip Diet
Role: PRINCIPAL_INVESTIGATOR
Dietition on Staff, Alfred Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alfred Hospital
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Small Project Grant - T10513
Identifier Type: -
Identifier Source: secondary_id
Allied Health Grant - A10501
Identifier Type: -
Identifier Source: secondary_id
12/05
Identifier Type: -
Identifier Source: org_study_id