Heart FailurePhase 1NCT00163904
Can a Modified Fat Diet With Low Glycaemic Load Improve Insulin Sensitivity and Inflammatory Mediators in Overweight People With Chronic Heart Failure?
A Phase 1 study testing High mono-unsaturated fat/low carbohydrate diet and High carbohydrate/low fat diet in people with Heart Failure, run by Bayside Health at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- High mono-unsaturated fat/low carbohydrate diet and High carbohydrate/low fat diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2005to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking heart failure patients (New York Heart Association [NYHA] Classes 1 - 3) attending the Alfred Hospital outpatient clinic will be enrolled.
Who cannot join
- Patients will be excluded if they are below the healthy weight range (BMI < 25 kg/m2) or if they are morbidly obese (BMI > 35 kg/m2).
- Patients with heart failure NYHA Class 4 will be excluded due to their increased risk of developing cachexia.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
Fiona J Adams, BSc. Grad Dip Diet, +613 9276 3063 ext. 3063, f.adams@alfred.org.au
Rachel M Stoney, BSc. MDiet, PhD, +613 9276 3063 ext. 3063, r.stoney@alfred.org.au
About this study
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])
Read more
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.
Read the detailed description
There is an increasing prevalence of chronic heart failure (CHF) in Western societies. In the last decade, progress has been made in understanding the neurohormonal involvement in the progression of the disease and consequently, new treatments have been developed although the mortality rate still remains high. Chronic heart failure is associated with marked insulin resistance as well as increasing plasma levels of pro-inflammatory markers such as Tumor Necrosis Factor-alpha (TNF-alpha) and Interleukin-6 (IL-6) with increasing severity of the disease. This has recently become an area of increased research interest. In CHF, insulin resistance may be present even when blood glucose levels appear normal. Independently of its influence on risk of arteriosclerosis, insulin resistance supports further progression of heart failure. Hyperinsulinaemia has also been found to worsen symptomatic status in CHF patients.
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
- Heart Failure
- Being tested
- High mono-unsaturated fat/low carbohydrate diet, High carbohydrate/low fat diet
- Keywords
- Heart Failure, Inflammatory mediators, insulin sensitivity, overweight, high monounsaturated diet
- Medical subject headings
- Heart Failure, Insulin Resistance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High mono-unsaturated fat/low carbohydrate dietBehavioural
High carbohydrate/low fat dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
Blood lipids
Inflammatory mediators
HOMA
Secondary outcomes (2)
Heart Failure Quality of Life Questionnaire
6 minute walk test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Fiona J Adams, BSc. Grad Dip Diet, Principal investigator, Dietition on Staff, Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163904
- Sponsor's protocol ID
- 12/05
- Other IDs
- Small Project Grant - T10513, Allied Health Grant - A10501
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 1 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Modified Fat Diet With Low Glycaemic Load Improve Insulin Sensitivity and Inflammatory Mediators in Overweight People With Chronic Heart Failure?
- ClinicalTrials.gov ID
- NCT00163904
- Acronym / sponsor ID
- 12/05
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Inflammatory mediators, insulin sensitivity, overweight, high monounsaturated diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Jan 2005
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is an increasing prevalence of chronic heart failure (CHF) in Western societies. In the last decade, progress has been made in understanding the neurohormonal involvement in the progression of the disease and consequently, new treatments have been developed although the mortality rate still remains high. Chronic heart failure is associated with marked insulin resistance as well as increasing plasma levels of pro-inflammatory markers such as Tumor Necrosis Factor-alpha (TNF-alpha) and Interleukin-6 (IL-6) with increasing severity of the disease. This has recently become an area of increased research interest. In CHF, insulin resistance may be present even when blood glucose levels appear normal. Independently of its influence on risk of arteriosclerosis, insulin resistance supports further progression of heart failure. Hyperinsulinaemia has also been found to worsen symptomatic status in CHF patients.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English speaking heart failure patients (New York Heart Association [NYHA] Classes 1 - 3) attending the Alfred Hospital outpatient clinic will be enrolled.
Key exclusion criteria (2 listed)
- Patients will be excluded if they are below the healthy weight range (BMI < 25 kg/m2) or if they are morbidly obese (BMI > 35 kg/m2).
- Patients with heart failure NYHA Class 4 will be excluded due to their increased risk of developing cachexia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High mono-unsaturated fat/low carbohydrate diet | Behavioural | – |
| High carbohydrate/low fat diet | Behavioural | – |
Primary outcome
Body mass index (BMI)
Blood lipids
Inflammatory mediators
HOMA
2 secondary outcomes
Heart Failure Quality of Life Questionnaire
6 minute walk test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona J Adams, BSc. Grad Dip Diet principal investigator
Dietition on Staff, Alfred Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High mono-unsaturated fat/low carbohydrate diet and High carbohydrate/low fat diet in people with Heart Failure, run by Bayside Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona J Adams, BSc. Grad Dip Diet (+613 9276 3063, f.adams@alfred.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2007.