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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163904




Registration number
NCT00163904
Ethics application status
Date submitted
13/09/2005
Date registered
14/09/2005
Date last updated
1/08/2007

Titles & IDs
Public title
Can a Modified Fat Diet With Low Glycaemic Load Improve Insulin Sensitivity and Inflammatory Mediators in Overweight People With Chronic Heart Failure?
Scientific title
Can a Modified Fat Diet With Low Glycaemic Load Improve Insulin Sensitivity and Inflammatory Mediators in Overweight People With Chronic Heart Failure?
Secondary ID [1] 0 0
Small Project Grant - T10513
Secondary ID [2] 0 0
12/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Diet and Nutrition 0 0 0 0
Obesity
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - High mono-unsaturated fat/low carbohydrate diet
Behaviour - High carbohydrate/low fat diet

Behaviour: High mono-unsaturated fat/low carbohydrate diet


Behaviour: High carbohydrate/low fat diet
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Body mass index (BMI)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Blood lipids
Timepoint [2] 0 0
Primary outcome [3] 0 0
Inflammatory mediators
Timepoint [3] 0 0
Primary outcome [4] 0 0
HOMA
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Heart Failure Quality of Life Questionnaire
Timepoint [1] 0 0
Secondary outcome [2] 0 0
6 minute walk test
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- English speaking heart failure patients (New York Heart Association [NYHA] Classes 1 -
3) attending the Alfred Hospital outpatient clinic will be enrolled.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fiona J Adams, BSc. Grad Dip Diet
Address 0 0
Dietition on Staff, Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fiona J Adams, BSc. Grad Dip Diet
Address 0 0
Country 0 0
Phone 0 0
+613 9276 3063
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163904