NCT06563011

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

August 9, 2024

Last Update Submit

August 17, 2024

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

idiopathic pulmonary fibrosisnutritional assessmentdietary counselling

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    12 weeks

Study Arms (1)

Dependent Sample

OTHER

Before-after measurements will be made in the dependent sample.

Other: Counselling

Interventions

CounsellingOTHER

Tailored Dietary Counselling

Dependent Sample

Eligibility Criteria

Age60 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with IPF

You may not qualify if:

  • Not giving written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Sanatorium Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 32316662BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Counseling

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nurcan Yabancı Ayhan, PhD

    Ankara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 20, 2024

Study Start

September 5, 2023

Primary Completion

June 5, 2024

Study Completion

June 5, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Locations

TU(1)