Interstitial Lung DiseaseDT-ILDNCT06016959
Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
A study testing Dietetic intervention in people with Interstitial Lung Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Dietetic intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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:
- How easy it is to recruit ILD patients to see a dietitian
- Whether patients will attend dietetic appointments
- Whether food/nutrient intake is increased following dietetic intervention
- 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
- Being tested
- Dietetic intervention, Diet sheet (placebo)
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietetic interventionOther
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.
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)
| Study group | Role | What they receive |
|---|---|---|
| Individualised dietetic advice | Experimental | Participants will receive 5 sessions receiving individualised nutritional counselling advice from a registered dietitian. Receives: Other: Dietetic intervention |
| Diet sheet | Placebo comparator | Participants will receive a diet sheet around poor appetite. Receives: Other: Diet sheet (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number individuals recruited/Number individuals contacted
Measured: 8 months
Completion rate
Number individuals completing study/Number individuals randomised
Measured: 3 months
Compliance
3 months
Measured: Defined by increased energy & protein intake versus run-in (three-day diet-diaries).
Secondary outcomes (8)
Nutritional status (Malnutrition)
PG-Subjective Global Assessment (SGA) which is a nutrition assessment tool using clinical parameters including weight loss, GI symptoms \& functional capacity to diagnose malnutrition (Bauer et al., 2011).
Measured: 3 months
Nutritional status (gastrointestinal related symptoms)
Gastrointestinal symptoms will be measured via the Gastrointestinal Symptom Rating Scale (GSRS) to further understand severity and impact of gastrointestinal related symptoms. (Svedlund et al., 1988)
Measured: 3 months
Anthropometrics (weight)
Weight (kg) will be measured by VitaFit™ FCC/CE certified digital weighing scales provided during the first appointment or delivered at home, measured to an accuracy of 0.05kg. Dietitian led support for their use will be available.
Measured: 3 months
Anthropometrics (height)
Height (m) will be derived from the most recent lung function reports.
Measured: 3 months
Anthropometrics (Body Mass Index)
With the anthropometrics measured weight (kg) and height (m), this will be used to calculate Body Mass Index (BMI (kg/m2)).
Measured: 3 months
Handgrip strength
Optimum nutrition can support maintenance of muscle to support activities of daily living. A CAMRY™ digital hand dynamometer will be delivered at home. HGS (kg) measures maximum voluntary muscle strength by squeezing the dynamometer providing a grip measurement accurate to 0.1kg.
Measured: 3 months
Quality of Life (QoL)
Improved nutrition status may positively impact QoL. The King's Brief Interstitial Lung Disease Questionnaire (K-BILD), a 15-widely validated ILD-specific QoL questionnaire, will be used.
Measured: 3 months
Energy and Protein intake
Participants will undertake a three-day diet diary at baseline and at 3 months to measure intake of macro and micronutrients will be calculated by using the software NutriticsTM, including daily total energy and protein intake as well as other nutrients, if necessary.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start20 Jun 2023
- Primary completion28 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016959
- Sponsor's protocol ID
- 327224
- Acronym
- DT-ILD
- Status last verified
- Oct 2023
- First submitted
- 7 May 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Mar;169(3):687-697. doi: 10.1016/j.chest.2025.09.021. Epub 2025 Sep 25.
PubMed 41015200
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialist Dietetic Intervention in Malnourished Patients with Fibrotic ILD: a Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06016959
- Acronym / sponsor ID
- DT-ILD / 327224
- Conditions
- Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How easy it is to recruit ILD patients to see a dietitian
- Whether patients will attend dietetic appointments
- Whether food/nutrient intake is increased following dietetic intervention
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualised dietetic advice | Experimental | Other: Dietetic interventionParticipants will receive 5 sessions receiving individualised nutritional counselling advice from a registered dietitian. |
| Diet sheet | Placebo comparator | Other: Diet sheet (placebo)Participants will receive a diet sheet around poor appetite. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietetic interventionDietetic 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 | Individualised dietetic advice |
| 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) | Other | Diet sheet |
Primary outcome
Recruitment rate
Time frame: 8 months
Number individuals recruited/Number individuals contacted
Completion rate
Time frame: 3 months
Number individuals completing study/Number individuals randomised
Compliance
Time frame: Defined by increased energy & protein intake versus run-in (three-day diet-diaries).
3 months
8 secondary outcomes
Nutritional status (Malnutrition)
Time frame: 3 months
Nutritional status (gastrointestinal related symptoms)
Time frame: 3 months
Anthropometrics (weight)
Time frame: 3 months
Anthropometrics (height)
Time frame: 3 months
Anthropometrics (Body Mass Index)
Time frame: 3 months
Handgrip strength
Time frame: 3 months
Quality of Life (QoL)
Time frame: 3 months
Energy and Protein intake
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 41015200Kahai 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. 2026 Mar;169(3):687-697. doi: 10.1016/j.chest.2025.09.021. Epub 2025 Sep 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietetic intervention in people with Interstitial Lung Disease, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.