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Benefits of Standard ONS in Indian Adults

An observational, multicenter study to evaluate the benefits of regular intake of standard ONS (ENSURE®) in Indian Adults.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/05/018917
Enrollment
1500
Registered
2019-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

None listed

Sponsors

Abbott Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria: 1. 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

Design outcomes

Primary

MeasureTime frame
Measured weight kgTimepoint: Baseline to 12 weeks

Secondary

MeasureTime frame
Hand Grip- DynamometerTimepoint: Baseline to 12 weeks;Quality of Life: WHOQOL-BREFTimepoint: Baseline to 12 weeks

Countries

India

Contacts

Public ContactDr Ganesh Kadhe

Abbott Healthcare Pvt. Ltd.

ganesh.kadhe@abbott.com022-38161417

Outcome results

None listed

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