Benefits of Standard ONS in Indian Adults

January 13, 2022 updated by: Abbott Nutrition

An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560018
        • Subramanyam's Day Care Center
      • Bangalore, India, 560072
        • Sunidhi Health Centre
      • Bangalore, India, 560091
        • Dr.Vinay J. Clinic
      • Bangalore, India, 560100
        • Sri Sai Health Care Center
      • Chennai, India, 600001
        • Chandra Chest and Diabetes Care Center
      • Chennai, India, 600001
        • Dr. Srinivasan Clinic
      • Chennai, India, 600007
        • Vasavi Clinic
      • Chennai, India, 600011
        • Sree Narayana Nursing Home
      • Chennai, India, 600018
        • Adhiparasakthi Clinic
      • Chennai, India, 600020
        • Sow-Krish Clinic
      • Chennai, India, 600028
        • Javantika Clinic
      • Chennai, India, 600040
        • Prime Family Medical Centre
      • Chennai, India, 600050
        • Dr. U. V. Mohan Clinic
      • Chennai, India, 600091
        • Dr. S. Nagrajan Clinic
      • Chennai, India, 600100
        • Vcure Clinic
      • Chennai, India, 600107
        • Dr. Sriram V. Clinic
      • Delhi, India, 110032
        • Goel Clinic
      • Delhi, India, 110051
        • Joshi Clinic
      • Delhi, India, 110053
        • Sharma Clinic
      • Delhi, India, 110091
        • Jain Clinic
      • Delhi, India, 110092
        • Sanjeevan Clinic
      • Howrah, India, 711101
        • Dr. Asoktaru Sengupta Clinic
      • Howrah, India, 711109
        • Dr. Mridul Bera Clinic
      • Hyderabad, India, 500016
        • Dr. Jagdish singh Clinic
      • Hyderabad, India, 500060
        • Geetha Hospital
      • Hyderabad, India, 500081
        • Maxcure Hospitals
      • Hyderabad, India, 500082
        • City Clinic
      • Kolkata, India, 700014
        • Healthy Lifestyle Clinic, Kolkata
      • Kolkata, India, 700017
        • Dass Medical Hall
      • Kolkata, India, 700063
        • Dr. Arabinda Halder Clinic
      • Kolkata, India, 700074
        • Dr. Parinata Roy Clinic
      • Kolkata, India, 700091
        • Dr. A. K. Chatterjee Clinic
      • Kolkata, India, 743101
        • Dr. O. P. Sharma Clinic
      • Mumbai, India, 400016
        • Qureshi Clinic
      • Mumbai, India, 400054
        • Contractor Clinic
      • Mumbai, India, 400056
        • Dhabolkar Clinic
      • Mumbai, India, 400064
        • Bhulchandani Hospital
      • Mumbai, India, 400067
        • Dr. S. Vikas Clinic
      • Mumbai, India, 400071
        • Ajitkumar Clinic
      • Secunderabad, India, 500002
        • Dr. A. Mahadev Clinic
      • Secunderabad, India, 500055
        • Gayatri Clinic
      • Thane, India, 400601
        • Boricha Clinic
      • Thane, India, 400605
        • Devrukhar Clinic
      • Thane, India, 400606
        • Pawar Clinic
      • Thane, India, 400610
        • Thakkar Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Out-patient healthcare clinics across India

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oral Nutritional Supplement (ONS)
2 servings per day ONS
Other: Oral Nutritional Supplement (ONS)
Per standard of care (SOC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline to 12 weeks
Measured weight kg
Baseline to 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Ganesh Kadhe, MD, Abbott Healthcare PVT. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2019

Primary Completion (Actual)

September 6, 2020

Study Completion (Actual)

September 6, 2020

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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