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

NCT06016959 | Completed

• 1 other identifier: 327224
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.How easy it is to recruit ILD patients to see a dietitian
2. 2.Whether patients will attend dietetic appointments
3. 3.Whether food/nutrient intake is increased following dietetic intervention
4. 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

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Number individuals recruited/Number individuals contacted

  8 months

• Completion rate

  Number individuals completing study/Number individuals randomised

  3 months

• Compliance

  3 months

  Defined by increased energy & protein intake versus run-in (three-day diet-diaries).

Secondary Outcomes (8)

• Nutritional status (Malnutrition)

  3 months

• Nutritional status (gastrointestinal related symptoms)

  3 months

• Anthropometrics (weight)

  3 months

• Anthropometrics (height)

  3 months

• Anthropometrics (Body Mass Index)

  3 months

Study Arms (2)

Individualised dietetic advice

EXPERIMENTAL

Participants will receive 5 sessions receiving individualised nutritional counselling advice from a registered dietitian.

Other: Dietetic intervention

Diet sheet

PLACEBO COMPARATOR

Participants will receive a diet sheet around poor appetite.

Other: Diet sheet (placebo)

Interventions

Dietetic intervention OTHER

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.

Individualised dietetic advice

Diet sheet (placebo) OTHER

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)

Diet sheet

Eligibility Criteria

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

You may qualify if:

• BMI ≤ 20kg/m2, or if aged \>75, BMI ≤ 21 (Righini et al., 2013)
• Over the past 12 months, unintentional weight loss ≥ 5% of body weight, regardless of baseline BMI or weight loss \>2 kg if BMI is normal.

You may not qualify if:

• Co-morbidities currently requiring a specialised diet (including enteral feeding)
• End of life care (estimated less than 6 weeks left to live)
• Expected introduction of anti-fibrotic or immunosuppressive treatment or introduction/increase corticosteroid dose during trial period
• Pregnancy
• Unable to give consent

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, United Kingdom

Location

Related Publications (1)

• Kahai R, Castelli G, Danzo F, Ferreira L, Srirangan A, Morviducci M, Mirabelli FM, Kaenmuang P, Roberts C, Bax S, Hewitt RJ, Kokosi M, Chua F, Kouranos V, Molyneaux PL, George PM, Jenkins RG, Banya W, Stock CJW, Jones S, Korff G, Duncan A, Wells AU, Sestini P, Renzoni EA. Specialist Dietary Intervention in Patients With Fibrotic Interstitial Lung Disease Experiencing Unintentional Weight Loss: A Pilot Randomized Controlled Trial. Chest. 2025 Sep 25:S0012-3692(25)05388-7. doi: 10.1016/j.chest.2025.09.021. Online ahead of print.

  PMID: 41015200 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: August 30, 2023
• Study Start: June 20, 2023
• Primary Completion: January 28, 2024
• Study Completion: June 1, 2024
• Last Updated: January 31, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)