Idiopathic Pulmonary FibrosisNCT06563011
The Assessment of Nutritional Status of Patients With IPF
A study testing Counselling in people with Idiopathic Pulmonary Fibrosis, run by İrem Çağla Özel at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated. Read more about this study
- Who is it for?
- Ages 60 to 84 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2023to 5 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 60 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with IPF
Who cannot join
- Not giving written consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Sanatorium Training and Research Hospital
Ankara
About this study
Official title: The Assessment of Nutritional Status of Patients With IPF and The Effectiveness of Nutritional Support
The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated.
A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, hand dynamometer, pulmonary function, and food frequency. Also quality of life were assessed by SGRQ. Tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.
Read the detailed description
Idiopathic pulmonary fibrosis (IPF) is an irreversible interstitial lung disease of unknown etiology, characterized by progressive loss of lung function. IPF is a disease of advanced age. Preliminary studies of IPF indicate that nutritional status may affect quality of life and prognosis, but the clinical significance of nutritional status has not been investigated. Weight loss is recognized as a common complication of IPF. There is no study that comprehensively evaluates the nutritional status of IPF patients in Turkey. The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated. A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, dynamometer, pulmonary function, and several questionnaires. so quality of life were assessed by SGRQ. All measurements were taken at the baseline. Then, tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Counselling
- Keywords
- idiopathic pulmonary fibrosis, nutritional assessment, dietary counselling
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounsellingOther
Tailored Dietary Counselling
| Study group | Role | What they receive |
|---|---|---|
| Dependent Sample | Other | Before-after measurements will be made in the dependent sample. Receives: Other: Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function
The effect of dietary counselling on change from baseline in FVC values at 12 weeks were assessed.
Measured: 12 weeks
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function-2
The effect of dietary counselling on change from baseline in DLCO values at 12 weeks were assessed.
Measured: 12 weeks
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on BMI
The effect of dietary counselling on change from baseline in BMI (kg/m2) at 12 weeks were assessed.
Measured: 12 weeks
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Body Composition
The effect of dietary counselling on change from baseline in body composition measured by BIA at 12 weeks were assessed.
Measured: 12 weeks
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Energy Intake
The effect of dietary counselling on change from baseline in energy intake (kcal/day) at 12 weeks were assessed.
Measured: 12 weeks
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Dietary Intake
The effect of dietary counselling on change from baseline in carbohydrate, protein and fat intake (kcal/day) at 12 weeks were assessed.
Measured: 12 weeks
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on HRQL
The effect of dietary counselling on change from baseline in St. George Respiratory Questionnaire (SGRQ) score at 12 weeks were assessed. Scores range from 0-100. While score of zero indicates normal, and a score of 100 indicates impaired quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start5 Sep 2023
- Primary completion5 Jun 2024
- Study completion5 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 Idiopathic Pulmonary FibrosisStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- İrem Çağla Özel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İrem Çağla Özel, Ankara University
- Investigators
- Nurcan Yabancı Ayhan, PhD, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563011
- Sponsor's protocol ID
- İ06-370-23
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Faverio P, Bocchino M, Caminati A, Fumagalli A, Gasbarra M, Iovino P, Petruzzi A, Scalfi L, Sebastiani A, Stanziola AA, Sanduzzi A. Nutrition in Patients with Idiopathic Pulmonary Fibrosis: Critical Issues Analysis and Future Research Directions. Nutrients. 2020 Apr 17;12(4):1131. doi: 10.3390/nu12041131.
PubMed 32316662
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Nutritional Status of Patients With IPF and The Effectiveness of Nutritional Support
- ClinicalTrials.gov ID
- NCT06563011
- Acronym / sponsor ID
- İ06-370-23
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- idiopathic pulmonary fibrosis, nutritional assessment, dietary counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- İrem Çağla ÖzelUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 20 Aug 2024 (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.
The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated.
A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, hand dynamometer, pulmonary function, and food frequency. Also quality of life were assessed by SGRQ. Tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.
Detailed description
Idiopathic pulmonary fibrosis (IPF) is an irreversible interstitial lung disease of unknown etiology, characterized by progressive loss of lung function. IPF is a disease of advanced age. Preliminary studies of IPF indicate that nutritional status may affect quality of life and prognosis, but the clinical significance of nutritional status has not been investigated. Weight loss is recognized as a common complication of IPF. There is no study that comprehensively evaluates the nutritional status of IPF patients in Turkey. The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated. A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, dynamometer, pulmonary function, and several questionnaires. so quality of life were assessed by SGRQ. All measurements were taken at the baseline. Then, tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dependent Sample | Other | Other: CounsellingBefore-after measurements will be made in the dependent sample. |
Who may qualify
- Ages
- 60 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with IPF
Key exclusion criteria (1 listed)
- Not giving written 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 |
|---|---|---|
| CounsellingTailored Dietary Counselling | Other | Dependent Sample |
Primary outcome
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function
Time frame: 12 weeks
The effect of dietary counselling on change from baseline in FVC values at 12 weeks were assessed.
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function-2
Time frame: 12 weeks
The effect of dietary counselling on change from baseline in DLCO values at 12 weeks were assessed.
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on BMI
Time frame: 12 weeks
The effect of dietary counselling on change from baseline in BMI (kg/m2) at 12 weeks were assessed.
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Body Composition
Time frame: 12 weeks
The effect of dietary counselling on change from baseline in body composition measured by BIA at 12 weeks were assessed.
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Energy Intake
Time frame: 12 weeks
The effect of dietary counselling on change from baseline in energy intake (kcal/day) at 12 weeks were assessed.
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Dietary Intake
Time frame: 12 weeks
The effect of dietary counselling on change from baseline in carbohydrate, protein and fat intake (kcal/day) at 12 weeks were assessed.
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on HRQL
Time frame: 12 weeks
The effect of dietary counselling on change from baseline in St. George Respiratory Questionnaire (SGRQ) score at 12 weeks were assessed. Scores range from 0-100. While score of zero indicates normal, and a score of 100 indicates impaired quality of life.
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 20 Aug 2024.
- Background: PubMed 32316662Faverio P, Bocchino M, Caminati A, Fumagalli A, Gasbarra M, Iovino P, Petruzzi A, Scalfi L, Sebastiani A, Stanziola AA, Sanduzzi A. Nutrition in Patients with Idiopathic Pulmonary Fibrosis: Critical Issues Analysis and Future Research Directions. Nutrients. 2020 Apr 17;12(4):1131. doi: 10.3390/nu12041131.
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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.
Nurcan Yabancı Ayhan, PhD study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counselling in people with Idiopathic Pulmonary Fibrosis, run by İrem Çağla Özel at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 20 Aug 2024. 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 Turkey (Türkiye). 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. 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?
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function (time frame: 12 weeks). The study lists 7 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 NCT06563011, 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 20 Aug 2024.