| CTRI Number |
CTRI/2017/09/009883 [Registered on: 22/09/2017] Trial Registered Prospectively |
| Last Modified On: |
21/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical
Other (Specify) [Nutritional intervention study using a food formulation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the effect of food formulation in patients with chronic obstructive pulmonary disease |
|
Scientific Title of Study
|
Impact of nutritional intervention on the nutritional status, oxidative stress and inflammation in patients with chronic obstructive pulmonary disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandan Vinay S |
| Designation |
Research Scholar |
| Affiliation |
DOS in Food Science & Nutrition, University of Mysore |
| Address |
Department of Studies in Food Science & Nutrition, Manasagangothri, University of Mysore, Mysuru, Karnataka, India
Mysore
KARNATAKA
570006
India |
| Phone |
7760219901 |
| Fax |
|
| Email |
knowdiet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asna Urooj |
| Designation |
Professor & HOD |
| Affiliation |
DOS in Food Science & Nutrition, University of Mysore |
| Address |
Department of Studies in Food Science & Nutrition, Manasagangothri, University of Mysore, Mysuru, Karnataka, India
Mysore
KARNATAKA
570006
India |
| Phone |
91821-2419632 |
| Fax |
91821-2419632 |
| Email |
asnau321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asna Urooj |
| Designation |
Professor & HOD |
| Affiliation |
DOS in Food Science & Nutrition, University of Mysore |
| Address |
Department of Studies in Food Science & Nutrition, Manasagangothri, University of Mysore, Mysuru, Karnataka, India
Mysore
KARNATAKA
570006
India |
| Phone |
91821-2419632 |
| Fax |
91821-2419632 |
| Email |
asnau321@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission Bahadur Shah Zafar Marg, ITO, Metro gate no.3, New Delhi, Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
University Grants Commission – Special Assistance Program II, UGC, New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chandan Vinay S |
JSS Medical College and Hospital, Mysore |
Department of Pulmonology, JSS Medical College multispeciality hospital, MG Road, Mysuru – 570015
Mysore
KARNATAKA |
7760219901
knowdiet@gmail.com |
| Chandan Vinay S |
University of Mysore |
Department of Studies in Food Science & Nutrition, Manasagangothri, University of Mysore, Mysuru, Karnataka, India – 570006
Mysore
KARNATAKA |
7760219901
knowdiet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics committee of JSS Medical College Mysore |
Approved |
| Institutional Human Ethics committee of University of Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Food formulation |
100 gram in divided amounts for a period of 6 months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. 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
|
|
| ExclusionCriteria |
| Details |
1.Patients with acute exacerbation of COPD
2.Patients with heart disease, cirrhosis, uncontrolled diabetes, chronic renal failure and clinically diagnosed infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome Name: Nutritional status – Body mass index, body composition, dietary intake Time-points: once in 4 weeks
Outcome Name: Antioxidant capacity, Time-point: once in 4 weeks
Outcome name: Inflammatory markers (C reactive protein, Tumor necrosis factor alpha), Time point: once in 4 weeks
Outcome name: Pulmonary function, Time point: once in 4 weeks
|
Once in four weeks for a period of six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Outcome name: BODE Index, Time point : once in 4 weeks
Outcome name: 6 minute walk test : Time point : once in 4 weeks
Outcome name: SGRQ score : Time point : once in 4 weeks
|
Once in four weeks for a period of six months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/11/2017 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a non-randomized, open blinded
quasi experimental nutritional intervention evaluating the effect of
nutritional intervention using a functional food formulation in 40 malnourished
subjects with COPD for a period of 6 months. The primary outcome measures are
their nutritional status and related alterations in body composition, lung
function, blood levels of oxidative stress and inflammatory markers and number
of exacerbations at initiation, during and completion of intervention period. The
secondary outcome measures are exercise capacity and quality of life at the initiation
and end of the intervention period. |