High energy diets and airway inflammation

Using high energy diets to induce inflammation in asthma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000236493

Acronym

FAT

Enrollment

129

Registered

2007-05-03

Start date

2007-02-08

Completion date

2010-02-02

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study examines the effect of a high energy intake on inflammation in asthma. We hypothesise that a high energy diet will cause an increase in both systemic and airway inflammation. Subjects are randomly assigned to a high energy or low energy diet for 24 hours. Systemic and airway inflammation will be assessed at 0, 4 and 24 hours.

Interventions

The second phase of the study intervention is a 4hour dietary challenge model instead of the 24hr dietary challenge model previously identified.The study will be a randomised ,controlled, single blinded, parallel trial with 3 groups, each using a 4 hour dietary challenge of an equicaloric meal of varying macro nutrient composition.In each group the participants will receive one meal consisting of 800 calories

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults with asthma and healthy controls

Exclusion criteria

Abnormal blood pressure- Abnormal heart rhythms- Abnormal blood cholesterol levels- Obesity (Body Mass Index (BMI) >30)- History of coronary heart disease, diabetes or familial lipid disorders- Use of blood pressure or lipid-lowering drugs or oral corticosteroids.

Outcome results