Benefits of Standard ONS in Indian Adults

Poor Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03713463
• Other study ID #: DA18
• Status: Terminated
• Start date: July 4, 2019
• Est. completion date: September 6, 2020

Study information

• Verified date: January 2022
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: September 6, 2020
• Est. primary completion date: September 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Poor Nutrition

Intervention

Other:
• Oral Nutritional Supplement (ONS)
Per standard of care (SOC)

Locations

Country	Name	City	State
India	Dr.Vinay J. Clinic	Bangalore
India	Sri Sai Health Care Center	Bangalore
India	Subramanyam's Day Care Center	Bangalore
India	Sunidhi Health Centre	Bangalore
India	Adhiparasakthi Clinic	Chennai
India	Chandra Chest and Diabetes Care Center	Chennai
India	Dr. S. Nagrajan Clinic	Chennai
India	Dr. Srinivasan Clinic	Chennai
India	Dr. Sriram V. Clinic	Chennai
India	Dr. U. V. Mohan Clinic	Chennai
India	Javantika Clinic	Chennai
India	Prime Family Medical Centre	Chennai
India	Sow-Krish Clinic	Chennai
India	Sree Narayana Nursing Home	Chennai
India	Vasavi Clinic	Chennai
India	Vcure Clinic	Chennai
India	Goel Clinic	Delhi
India	Jain Clinic	Delhi
India	Joshi Clinic	Delhi
India	Sanjeevan Clinic	Delhi
India	Sharma Clinic	Delhi
India	Dr. Asoktaru Sengupta Clinic	Howrah
India	Dr. Mridul Bera Clinic	Howrah
India	City Clinic	Hyderabad
India	Dr. Jagdish singh Clinic	Hyderabad
India	Geetha Hospital	Hyderabad
India	Maxcure Hospitals	Hyderabad
India	Dass Medical Hall	Kolkata
India	Dr. A. K. Chatterjee Clinic	Kolkata
India	Dr. Arabinda Halder Clinic	Kolkata
India	Dr. O. P. Sharma Clinic	Kolkata
India	Dr. Parinata Roy Clinic	Kolkata
India	Healthy Lifestyle Clinic, Kolkata	Kolkata
India	Ajitkumar Clinic	Mumbai
India	Bhulchandani Hospital	Mumbai
India	Contractor Clinic	Mumbai
India	Dhabolkar Clinic	Mumbai
India	Dr. S. Vikas Clinic	Mumbai
India	Qureshi Clinic	Mumbai
India	Dr. A. Mahadev Clinic	Secunderabad
India	Gayatri Clinic	Secunderabad
India	Boricha Clinic	Thane
India	Devrukhar Clinic	Thane
India	Pawar Clinic	Thane
India	Thakkar Clinic	Thane

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Measured weight kg	Baseline to 12 weeks
Secondary	Hand Grip	Dynamometer	Baseline to 12 weeks
Secondary	Quality of Life (QoL)	World Health Organization QOL-BREF Questionnaire; 4 Domain scores scaled in a positive direction (very dissatisfied - very satisfied)	Baseline to 12 weeks