A study to assess the effect of food formulation in patients with chronic obstructive pulmonary disease

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: CTRI/2017/09/009883
• Lead Sponsor: University Grants Commission

Brief Summary

This study is a non-randomized, open blindedquasi experimental nutritional intervention evaluating the effect ofnutritional intervention using a functional food formulation in 40 malnourishedsubjects with COPD for a period of 6 months. The primary outcome measures aretheir nutritional status and related alterations in body composition, lungfunction, blood levels of oxidative stress and inflammatory markers and numberof exacerbations at initiation, during and completion of intervention period. Thesecondary outcome measures are exercise capacity and quality of life at the initiationand end of the intervention period.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects of both genders diagnosed with COPD 2.
• Age:- between 40-75 years 3.
• Subjects with BMI < 20 kg/m2 and (or) PGSGA rating of ‘C’ and with deficits in calorie intake of < 75% the recommended dietary intake 4.
• Patients without a history of or ongoing nutritional therapy.

Exclusion Criteria

1.Patients with acute exacerbation of COPD 2.Patients with heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure and clinically diagnosed infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome Name: Antioxidant capacity, Time-point: once in 4 weeks	Once in four weeks for a period of six months
Outcome Name: Nutritional status – Body mass index, body composition, dietary intake Time-points: once in 4 weeks	Once in four weeks for a period of six months
Outcome name: Inflammatory markers (C reactive protein, Tumor necrosis factor alpha), Time point: once in 4 weeks	Once in four weeks for a period of six months
Outcome name: Pulmonary function, Time point: once in 4 weeks	Once in four weeks for a period of six months

Secondary Outcome Measures

Name	Time	Method
Outcome name: BODE Index, Time point : once in 4 weeks	Outcome name: 6 minute walk test : Time point : once in 4 weeks

Trial Locations

Locations (2)

JSS Medical College and Hospital, Mysore; 🇮🇳 Mysore, KARNATAKA, India

University of Mysore; 🇮🇳 Mysore, KARNATAKA, India

JSS Medical College and Hospital, Mysore

🇮🇳Mysore, KARNATAKA, India

Chandan Vinay S

Principal investigator

7760219901

knowdiet@gmail.com