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Effect of Oral Nutritional Supplement in Post surgical recovery

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074961
Enrollment
60
Registered
2024-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: K908- Other intestinal malabsorption

Interventions

Intervention1: 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 Co

Sponsors

Dutch Medical Food
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 consumptionTimepoint: 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 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 Timepoint: Day 0, Day 1, Day 28, Day 56, Day 84—

Countries

India

Contacts

Public ContactDr R Jai Vinod Kumar

Apollo Speciality Hospitals Ayanambakkam Chennai

drjaivinod@gmail.com9941326116

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026