Study Stopped
COVID-19 enrollment challenges
Benefits of Standard ONS in Indian Adults
An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
1 other identifier
observational
59
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2019
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedStudy Start
First participant enrolled
July 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2020
CompletedJanuary 28, 2022
January 1, 2022
1.2 years
October 18, 2018
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Weight
Measured weight kg
Baseline to 12 weeks
Secondary Outcomes (2)
Hand Grip
Baseline to 12 weeks
Quality of Life (QoL)
Baseline to 12 weeks
Study Arms (1)
Oral Nutritional Supplement (ONS)
2 servings per day ONS
Interventions
Eligibility Criteria
Out-patient healthcare clinics across India
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (45)
Subramanyam's Day Care Center
Bangalore, 560018, India
Sunidhi Health Centre
Bangalore, 560072, India
Dr.Vinay J. Clinic
Bangalore, 560091, India
Sri Sai Health Care Center
Bangalore, 560100, India
Chandra Chest and Diabetes Care Center
Chennai, 600001, India
Dr. Srinivasan Clinic
Chennai, 600001, India
Vasavi Clinic
Chennai, 600007, India
Sree Narayana Nursing Home
Chennai, 600011, India
Adhiparasakthi Clinic
Chennai, 600018, India
Sow-Krish Clinic
Chennai, 600020, India
Javantika Clinic
Chennai, 600028, India
Prime Family Medical Centre
Chennai, 600040, India
Dr. U. V. Mohan Clinic
Chennai, 600050, India
Dr. S. Nagrajan Clinic
Chennai, 600091, India
Vcure Clinic
Chennai, 600100, India
Dr. Sriram V. Clinic
Chennai, 600107, India
Goel Clinic
Delhi, 110032, India
Joshi Clinic
Delhi, 110051, India
Sharma Clinic
Delhi, 110053, India
Jain Clinic
Delhi, 110091, India
Sanjeevan Clinic
Delhi, 110092, India
Dr. Asoktaru Sengupta Clinic
Howrah, 711101, India
Dr. Mridul Bera Clinic
Howrah, 711109, India
Dr. Jagdish singh Clinic
Hyderabad, 500016, India
Geetha Hospital
Hyderabad, 500060, India
Maxcure Hospitals
Hyderabad, 500081, India
City Clinic
Hyderabad, 500082, India
Healthy Lifestyle Clinic, Kolkata
Kolkata, 700014, India
Dass Medical Hall
Kolkata, 700017, India
Dr. Arabinda Halder Clinic
Kolkata, 700063, India
Dr. Parinata Roy Clinic
Kolkata, 700074, India
Dr. A. K. Chatterjee Clinic
Kolkata, 700091, India
Dr. O. P. Sharma Clinic
Kolkata, 743101, India
Qureshi Clinic
Mumbai, 400016, India
Contractor Clinic
Mumbai, 400054, India
Dhabolkar Clinic
Mumbai, 400056, India
Bhulchandani Hospital
Mumbai, 400064, India
Dr. S. Vikas Clinic
Mumbai, 400067, India
Ajitkumar Clinic
Mumbai, 400071, India
Dr. A. Mahadev Clinic
Secunderabad, 500002, India
Gayatri Clinic
Secunderabad, 500055, India
Boricha Clinic
Thane, 400601, India
Devrukhar Clinic
Thane, 400605, India
Pawar Clinic
Thane, 400606, India
Thakkar Clinic
Thane, 400610, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ganesh Kadhe, MD
Abbott Healthcare PVT. LTD.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2018
First Posted
October 19, 2018
Study Start
July 4, 2019
Primary Completion
September 6, 2020
Study Completion
September 6, 2020
Last Updated
January 28, 2022
Record last verified: 2022-01