| CTRI Number |
CTRI/2025/01/079566 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Effect of adding an oral concentrated liquid protein source to dietary counselling in patients with Chronic Obstructive Pulmonary Disease (COPD) |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Mohanakrishnan |
| Designation |
Consultant, Pulmonology & Sleep specialist |
| Affiliation |
Apollo Speciality Hospitals Ayanambakkam Chennai |
| Address |
07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095
Chennai TAMIL NADU 600095 India |
| Phone |
9941156479 |
| Fax |
|
| Email |
drmkpulmo@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr J Mohanakrishnan |
| Designation |
Consultant, Pulmonology & Sleep specialist |
| Affiliation |
Apollo Speciality Hospitals Ayanambakkam Chennai |
| Address |
07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095
TAMIL NADU 600095 India |
| Phone |
9941156479 |
| Fax |
|
| Email |
drmkpulmo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr J Mohanakrishnan |
| Designation |
Consultant, Pulmonology & Sleep specialist |
| Affiliation |
Apollo Speciality Hospitals Ayanambakkam Chennai |
| Address |
07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095
TAMIL NADU 600095 India |
| Phone |
9941156479 |
| Fax |
|
| Email |
drmkpulmo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dutch Medical Foods Door no 12/29 Plot no 14/1B Ranjith Road, Kotturpuram Chennai 600085 |
|
|
Primary Sponsor
|
| Name |
Dutch Medical Food |
| Address |
Door no 12/29 Plot no 14/1B Ranjith Road, Kotturpuram Chennai600085 |
| Type of Sponsor |
Other [Neutraceuticals] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr J Mohanakrishnan |
Apollo Speciality Hospitals |
07, Cardiac OPD, 1st Floor, Annex building, Apollo Speciality Hospitals, No. 64, Off P.H. Road, Vanagaram to Ambattur main road, Ayanambakkam, Chennai - 600095
Chennai TAMIL NADU |
9941156479
drmkpulmo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Biomedical Research, Apollo Hospitals, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dietary counselling |
Dietary counselling
Duration 90 Days |
| Intervention |
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 |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effects of an oral nutritional supplement ONS taken with dietary counseling vs dietary counseling among COPD patients
1.Protein consumption
|
Day 0, Day 1, Day 28, Day 56. Day 84
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
Day 0, Day 1, Day 28, Day 56, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Almost 90% of COPD deaths occur in low- and middle-income countries, where effective strategies for prevention and control are not always implemented or accessible. Several key aspects of managing nutritional complications in COPD must be addressed, from assessing nutritional needs to implementing dietary strategies. Regular assessment of weight, BMI, and dietary intake is crucial for identifying and addressing nutritional issues early. This study will explore and inform the development of appropriate nutrition intervention strategies to improve the nutritional status, functional capacity, and thus QoL of patients with COPD. The primary objective is to compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling alone on Protein consumption. The secondary objective is to to compare the effects of an oral nutritional supplement (ONS) taken with dietary counseling vs. dietary counseling alone on Energy Consumption, Total food intake, Serum Total Protein, Serum Albumin: Globulin (A/G) ratio, Quality of life, Change in BMI, Change in Body weight, Hand grip strength will be assessed using a dynamometer at baseline and the end of the study and Distance walked 6 mins (or 12 mins) at baseline and the end of the study. PI Max and PE Max will be measured to assess lung function and will be recorded using spirometry. The Energy, protein intake will be assessed at baseline, weeks 4, 8 and 12 using a food diary distributed by study personnel Blood drawn at baseline and at the end of the study will be used to assess serum protein and ratio of serum albumin to globulin. Quality of life and COPD severity will be assessed at baseline, weeks 4, 8 and 12 using SF-36questionnaire.Compliance will be calculated as the amount of ONS consumed in proportion to prescribed calories and Safety will be assessed at baseline and at each visit until the end of the study. |