Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: High Protein Energy Dense Nutritional Supplement HPEDNS paste: A peanut based HPEDNS paste 100 g per day in three dosage regimens Arm A 33 g thrice daily Arm B 50 g twice daily and Arm
Sponsors
Compact India Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female aged between and equal to 35 and 70 years Subject with a confirmed diagnosis of CRD attending respiratory outpatient clinics Subject with Malnutrition Universal Screening Tool score of equal to or greater than 1 Subject having ability to complete a self administered questionnaire and subject diary Subject who has given written informed consent
Exclusion criteria
Exclusion criteria: Subject having severe dysphagia swallowing difficulties who is not able to consume oral solids semisolids Subject with peanut allergy food allergy or intolerance for any of the ingredients used in the HPEDNS paste Subject with co morbidities affecting taste or smell function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who have consumed equal to greater than 80 percent of prescribed sachets and prescribed dosage in gram of the HPEDNS paste among three dosage regimen groupsTimepoint: Day0 Day3 Day15 Day21 Day30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Detailed organoleptic evaluation score using a 5point Just About Right scale Overall liking of the HPEDNS paste using a 10point hedonic scale Proportion of subjects who have experienced no sickness or functional issues across organ systems Change in body composition and blood markers over 30 days among three dosage regimens Change in energy and physical function over 30 days among three dosage regimens Factors affecting adherence with daily intake of HPEDNS paste Proportion of subjects having preference for HPEDNS intake medium across direct solid vehicle and liquid vehicle Proportion of subjects having feeling of satiety or avoidance of meals with HPEDNS intake among three dosage regimens Proportion of subjects experiencing adverse events during 30 day study period among three dosage regimensTimepoint: Day 0 day 3 day 15 Day 21 Day 30 | — |
Countries
India
Contacts
Public ContactDr Ankit Pathak
WorkSure MedPharma Consultancy India Private Limited
Outcome results
None listed