Benefits of Standard ONS in Indian Adults

Recruiting

• Conditions: Poor Nutritional Status

• Registration Number: CTRI/2019/05/018917
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

Different studies in India have shown that more than 50% ofadult population of India are suffering from malnutrition and more than 90%have less than recommended intake. Nutritional status and handgrip strengthimproved significantly with ONS. In already malnourished subjects it may be toolate to include improvement so prevention is key, so all elderly subjects needto be assessed and intervention initiated early. The current study has beendesigned as there is not sufficient Indian data available on the benefits ofusing ONS in patients. This is a prospective, single arm, baseline-controlledmulticenter study to observe benefits on Oral Nutritional Supplement (ONS)intake in adults with medical conditions associated with poor nutritionalstatus.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-05-07
• Study Start: 2019-08-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Ambulatory adult patients >or equal to 45 years of age 2.
• Patients at the risk of malnutrition (MST > or equal to 2) 3.
• Patients who understand nature of the study, willing to participate in all scheduled visits and trial procedures & provide a written informed consent.

Exclusion Criteria

• Subject using commercially available macronutrient food supplements or another ONS 2.
• History or evidence of hypersensitivity to any component of study product 3.
• History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food 4.
• Evidence of active TB, Hepatitis B, Hepatitis C or HIV infection, type 1 or type 2 diabetes mellitus, malignancy and any other disease affecting appetite and weight loss 5.
• History or evidence of any medical condition that in the opinion of Investigator can interfere with the study assessment of outcome or Patients with scheduled surgery during the duration of the study 6.
• Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments 7.
• Pregnant or lactating women.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured weight kg	Baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Hand Grip- Dynamometer	Baseline to 12 weeks
Quality of Life: WHOQOL-BREF	Baseline to 12 weeks

Trial Locations

Locations (70)

Adhiparasakthi Clinic; 🇮🇳 Chennai, TAMIL NADU, India

Ajitkumar Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Bhanot Clinic; 🇮🇳 East, DELHI, India

Bhulchandani Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Boricha Clinic; 🇮🇳 Thane, MAHARASHTRA, India

Chandi Clinic; 🇮🇳 East, DELHI, India

Chandra Chest and Diabetes Care Center; 🇮🇳 Chennai, TAMIL NADU, India

City Clinic; 🇮🇳 Hyderabad, TELANGANA, India

Contractor Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Dass Medical Hall; 🇮🇳 Kolkata, WEST BENGAL, India

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Adhiparasakthi Clinic

🇮🇳Chennai, TAMIL NADU, India

Dr V S Natarajan

Principal investigator

9500078740

dr_v_s_natarajan@yahoo.com