Benefits of Standard ONS in Indian Adults

Terminated

• Conditions: Poor Nutrition

• Registration Number: NCT03713463
• Lead Sponsor: Abbott Nutrition

Brief Summary

This is a prospective, single arm, baseline-controlled multicenter study to observe benefits on Oral Nutritional Supplement (ONS) intake in adults with medical conditions associated with poor nutritional status.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-19
• Study Start: 2019-07-04
• Primary Completion: 2020-09-06
• Study Completion: 2020-09-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Ambulatory adult patients >or equal to 45 years of age
• Patients at the risk of malnutrition (MST > or equal to 2)
• 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
• History or evidence of hypersensitivity to any component of study product
• History of any Gastrointestinal disorder/surgery that affects digestion and/or absorption of food
• 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
• 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
• Subjects who are unlikely to comply with the study protocol or follow up regularly for study assessments
• Pregnant or lactating women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight	Baseline to 12 weeks	Measured weight kg

Secondary Outcome Measures

Name	Time	Method
Hand Grip	Baseline to 12 weeks	Dynamometer
Quality of Life (QoL)	Baseline to 12 weeks	World Health Organization QOL-BREF Questionnaire; 4 Domain scores scaled in a positive direction (very dissatisfied - very satisfied)

Trial Locations

Locations (45)

Subramanyam's Day Care Center; 🇮🇳 Bangalore, India

Sunidhi Health Centre; 🇮🇳 Bangalore, India

Dr.Vinay J. Clinic; 🇮🇳 Bangalore, India

Sri Sai Health Care Center; 🇮🇳 Bangalore, India

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

Dr. Srinivasan Clinic; 🇮🇳 Chennai, India

Vasavi Clinic; 🇮🇳 Chennai, India

Sree Narayana Nursing Home; 🇮🇳 Chennai, India

Adhiparasakthi Clinic; 🇮🇳 Chennai, India

Sow-Krish Clinic; 🇮🇳 Chennai, India

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