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NCT Number: NCT06563011

The Assessment of Nutritional Status of Patients With IPF

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

60 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk Sanatorium Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with IPF

Exclusion criteria

  • Not giving written consent

Treatment and study plan

Counselling

Other

Tailored Dietary Counselling

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

İrem Çağla Özel

Other

Registry information

Official study title

The Assessment of Nutritional Status of Patients With IPF and The Effectiveness of Nutritional Support

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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