Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial

Summary

Malnutrition occurs when the body receives too few nutrients, resulting in health problems such as weight loss. The consequences of malnutrition are worrying as they include lung failure, infection, and pressure ulcers.

Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and burning off energy. Additionally, medications called anti-fibrotic agents are used to slow disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting and weight loss which can result in malnutrition.

Malnutrition occurs in ILD in approximately half of patients. This is important because the main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes into consideration your weight against your height, are linked with worse outcomes in ILD. Malnutrition in ILD can also reduce eligibility for lung transplant and can impact tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is limited.

Dietitians play a key role in diagnosis and treatment of malnutrition. This is because dietary counselling by a dietitian has been shown to increase quality of life and intake of energy in other chronic diseases. There are currently no studies documenting the benefits of dietetic intervention in patients with ILD.

We propose to undertake the first feasibility study in this area. A feasibility study is a first step trial which investigates whether a study can \& should be done. The main aims of this study are:

1. How easy it is to recruit ILD patients to see a dietitian
2. Whether patients will attend dietetic appointments
3. Whether food/nutrient intake is increased following dietetic intervention
4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this study will also provide initial information about whether dietetic intervention stabilises weight, BMI \& quality of life.

Conditions

• Interstitial Lung Disease

Interventions

OTHER

Dietetic intervention

Dietetic intervention involves individualised and tailored dietary advice to patients struggling with their nutrition. This includes optimising energy and protein intake to improve malnutrition \& also giving dietary advice to support with nutrition impact symptoms e.g. bloating.

OTHER

Diet sheet (placebo)

Patients randomised into the group receiving a diet sheet will be sent out Royal Brompton \& Harefield Hospital's Poor Appetite diet booklet which involves general strategies to improve nutritional status (energy and protein)

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2024-01-28

Completion

2024-06-01

Countries

• United Kingdom

Study Locations