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Effect of adding an oral concentrated liquid protein source to dietary counselling in patients with Chronic Obstructive Pulmonary Disease (COPD)

Comparing nutrient intake, functional capacity and quality of life in adults with COPD, given either an oral nutritional protein supplement with dietary counselling or receiving dietary counselling alone - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079566
Enrollment
80
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J399- Disease of upper respiratory tract, unspecified

Interventions

Intervention1: Protimedic an Oral Nutritional supplement and Dietary counselling: Dose: Two 10g protein in 20ml Sachets Dosage form: liquid form Frequency: Twice a Day bid Duration: 90 Days Control I

Sponsors

Dutch Medical Food
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. COPD stage 2, stage 3, stage 4 2. Medium to high degree of malnourishment according to MUST. 3. Subject must be able to eat and drink. 4. Subject must be free living. 5. Subject must be able to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with Liver, Heart or Kidney failure. 2. Subjects with Malignancy 3. Subjects with fever or pulmonary disease in addition to COPD. 4. Subjects with dysphagia 5. Subjects with poorly controlled diabetes. 6. Subjects with any disease state resulting in abnormal (high) A/G ratio. 7. Subjects receiving end of life care. 8. Subjects with known allergies to Milk and Collagen. 9. Subjects who are unable to provide informed consent. 10. Subjects with already taking health supplements

Design outcomes

Primary

MeasureTime frame
To compare the effects of an oral nutritional supplement ONS taken with dietary counseling vs dietary counseling among COPD patients 1.Protein consumption Timepoint: Day 0, Day 1, Day 28, Day 56. Day 84

Secondary

MeasureTime frame
To compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling among COPD patients 1. Energy Consumption 2. Total food intake 3. Serum Total Protein 4. Serum Albumin: Globulin (A/G) ratio 5. Quality of life 6. Change in BMI 7. Change in Body weight 8. Hand grip strength will be assessed using a dynamometer at baseline and the end of the study 9. Distance walked 6 mins (or 12 mins) at baseline and the end of the study. Timepoint: Day 0, Day 1, Day 28, Day 56, Day 84

Countries

India

Contacts

Public ContactDr J Mohanakrishnan

Apollo Speciality Hospitals Ayanambakkam Chennai

drmkpulmo@gmail.com9941156479

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026