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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06016959
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease

Arms & Interventions

Arms

Experimental: Individualised dietetic advice

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

Placebo Comparator: Diet sheet

Participants will receive a diet sheet around poor appetite.

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.