| CTRI Number |
CTRI/2024/10/074961 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Oral Nutritional Supplement in Post surgical recovery |
|
Scientific Title of Study
|
Comparing nutrient intake and quality of life during the post-surgical recovery period in malnourished adults given either an oral nutritional 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 R Jai Vinod Kumar |
| Designation |
Senior Consultant, General and Laproscopic Surgery |
| Affiliation |
Apollo Speciality Hospitals Ayanambakkam Chennai |
| Address |
Room no 11 OPD 1 Ground floor, General surgery department, Main block Apollo Speciality Hospitals,
No. 64, Off P.H. Road,
Vanagaram to Ambattur main road,
Ayanambakkam, Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9941326116 |
| Fax |
|
| Email |
drjaivinod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Jai Vinod Kumar |
| Designation |
Senior Consultant, General and Laproscopic Surgery |
| Affiliation |
Apollo Speciality Hospitals Ayanambakkam Chennai |
| Address |
Room no 11 OPD 1 Ground floor, General surgery department, Main block Apollo Speciality Hospitals,
No. 64, Off P.H. Road,
Vanagaram to Ambattur main road,
Ayanambakkam, Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9941326116 |
| Fax |
|
| Email |
drjaivinod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Jai Vinod Kumar |
| Designation |
Senior Consultant, General and Laproscopic Surgery |
| Affiliation |
Apollo Speciality Hospitals Ayanambakkam Chennai |
| Address |
Room no 11 OPD 1 Ground floor, General surgery department, Main block Apollo Speciality Hospitals,
No. 64, Off P.H. Road,
Vanagaram to Ambattur main road,
Ayanambakkam, Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9941326116 |
| Fax |
|
| Email |
drjaivinod@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dutch Medical Food12/29, Plot No:14/1 B, Ranjith Road, Kotturpuram, Chennai-600085 |
|
|
Primary Sponsor
|
| Name |
Dutch Medical Food |
| Address |
Door no 12/29
Plot no 14/1B
Ranjith Road, Kotturpuram Chennai 600085 |
| 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 R Jai Vinod Kumar |
Apollo Speciality Hospitals |
Room no 11 OPD 1 Ground floor Main block Apollo Speciality Hospitals,
No. 64, Off P.H. Road,
Vanagaram to Ambattur main road,
Ayanambakkam, Chennai 600095
Chennai
TAMIL NADU |
9941326116
drjaivinod@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: K908||Other intestinal malabsorption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dietary counselling |
Dietary counselling
Duration 90Days |
| Intervention |
Flex Compact an Oral Nutritional Supplement and Dietary counseling
|
Dose: 3.0 Kcal/ml
Dosage form: Powder form
Frequency: Twice a day bid dosing
Duration: 90Days
Dietary counseling |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults over 50 years with disease related malnourished adults who are post-op surgery.
2. Medium to a high degree of malnourishment, according to MUST.
3. The subject must be able to eat and drink.
4. The subject must be free living.
5. The subject must be able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects hospitalised for acute conditions impacting their metabolism.
2. Subjects with galactosemia or lactose intolerance.
3. Subjects with chronic kidney disease requiring dialysis.
4. Subjects taking other forms of nutritional support.
5. Subjects with dysphagia, malabsorption or related GI disorders, poorly controlled diabetes, active malignancies, or liver failure.
6. Subjects with any disease state resulting in abnormal (high) A/G ratio.
7. Subjects receiving end-of-life care.
8. Subjects living in an institution.
9. Subjects participating in another clinical trial.
10. Subjects with known allergies to ingredients in the ONS.
11. Subjects who are unable to provide informed consent.
|
|
|
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 counselling vs. dietary counselling alone among malnourished adults in laparoscopic post-surgical recovery period on the following:
1. Energy consumption
2. 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 counselling vs. dietary counselling alone among laparoscopic post-surgical recovery period in malnourished adults on the following
1. Total food intake
2. Serum Total Protein
3. Serum Albumin: Globulin (A/G) ratio
4. Quality of life
5. Change in BMI
6. Change in Arm & Waist circumference
|
Day 0, Day 1, Day 28, Day 56, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/10/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Oral supplements can be crucial postoperative care by supporting recovery, providing essential nutrients, and promoting overall health. Adequate nutrition is essential for wound healing, tissue repair, and immune function after surgery. To compare the effects of Flex Compact an oral nutritional supplement (ONS) taken with dietary counselling vs. dietary counselling alone among malnourished adults in laparoscopic post-surgical recovery period on Energy consumption and Protein consumption. The secondary Objective is to compare the effects of an oral nutritional supplement (ONS) taken with dietary counselling vs. dietary counselling alone on total colorie intake, Serum Total Protein, Serum Albumin: Globulin (A/G) ratio, Quality of Life and Change in BMI. The Energy, protein and total food intake will be assessed at baseline, weeks 4, 8 and 12 using a 3-day recall 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 will be assessed at baseline, weeks 4, 8 and 12 using SF-36 questionnaire. 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. |