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

NCT00163904 | Unknown Phase 1

• 3 other identifiers: 12/05Small Project Grant - T10513Allied Health Grant - A10501
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Inflammatory mediators; insulin sensitivity; overweight; high monounsaturated diet

Outcome Measures

Primary Outcomes (4)

• Body mass index (BMI)

• Blood lipids

• Inflammatory mediators

• HOMA

Secondary Outcomes (2)

• Heart Failure Quality of Life Questionnaire

• 6 minute walk test

Interventions

High mono-unsaturated fat/low carbohydrate diet BEHAVIORAL

High carbohydrate/low fat diet BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking heart failure patients (New York Heart Association \[NYHA\] Classes 1 - 3) attending the Alfred Hospital outpatient clinic will be enrolled.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayside Health: lead

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Heart Failure; Insulin Resistance; Overweight

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fiona J Adams, BSc. Grad Dip Diet

  Dietition on Staff, Alfred Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona J Adams, BSc. Grad Dip Diet

CONTACT

+613 9276 3063; f.adams@alfred.org.au

Rachel M Stoney, BSc. MDiet, PhD

CONTACT

+613 9276 3063; r.stoney@alfred.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 14, 2005
• Study Start: January 1, 2005
• Last Updated: August 1, 2007

Record last verified: 2005-09

Locations

AU (1)