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Efficacy of oral nutritional supplementation for interstitial lung disease with a tendency to weight loss

Efficacy of ONS for ILD with weight loss

Kawasaki Takeshi

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba

kawatake@chiba-u.jp

Kawasaki Takeshi

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba

+81-43-222-7171

kawatake@chiba-u.jp

Recruiting

July. 13, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Interstitial lung disease

From the treatment initiation period, 200 ml (2 packs) of Isocal 100 per day should be taken orally for 12 weeks.

Change in lean body mass (LBM) from baseline at 12 weeks (kg)

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

+81-43-222-7171

July. 03, 2023

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