Efficacy of ONS for ILD with weight loss

JRCT ID: jRCTs031230224

Registered date:13/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Interstitial lung disease
• Date of first enrollment: 13/07/2023
• Target sample size: 25
• Study type: Interventional
• Intervention(s): From the treatment initiation period, 200 ml (2 packs) of Isocal 100 per day should be taken orally for 12 weeks.

Outcome(s)

• Primary Outcome: Change in lean body mass (LBM) from baseline at 12 weeks (kg)

Secondary Outcome

Secondary efficacy endpoints.
(1) Dietary intake at 12 weeks and questionnaire assessment by SNAQ
(2) Weight, BMI and FFMI change at 12 weeks
(3) FVC change at 12 weeks
(4) Nutritional assessment by serum Alb, GNRI and CONUT score at 12 weeks
(5) Activity assessment by Barthel index and 6-minute walk test at 12 weeks
(6) QOL assessment by L-PF Impacts at 12 weeks.

Secondary safety endpoints
(1) All serious adverse events
(2) Adverse events with undeniable causal relationship to oral nutritional supplementation

Secondary endpoints of tolerability
Patients' assessment of Isocal 100

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with a diagnosis of interstitial lung disease.
2) Patients aged 20 years or older at the time of obtaining consent
3) Patients who have lost at least 2 kg in the last 12 months or have a BMI <20 kg/m2 in the last 12 months
4) Patients who have been fully informed of the study and who, on the basis of a thorough understanding of the study, have provided written consent to participate in the study.

Exclude criteria

1) Patients with coexisting malignant diseases
2) Patients with conditions that may further worsen their nutritional status, such as unstable diabetes mellitus
3) Patients already taking oral nutritional supplements at least once a week within the last 3 months
4) Patients receiving new medication within the past month for diarrhoea as a side effect of antifibrotic drugs
5) Patients allergic to milk, soya or gelatine, which are ingredients of Isocal 100
6) Patients who cannot give their consent
7) Other patients who are judged by the study investigator or sub-investigator to be unsuitable for the safe conduct of the study.

Related Information

• Primary Sponsor: Kawasaki Takeshi
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)