Clinical trial NCT03713463: Benefits of Standard ONS in Indian Adults
Official title: An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Poor Nutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2018-10-19
Enrollment: 59
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-patient healthcare clinics across India

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.


Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Hand Grip
timeFrame: Baseline to 12 weeks
measure: Quality of Life (QoL)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Subramanyam's Day Care Center
city: Bangalore
country: India
facility: Sunidhi Health Centre
city: Bangalore
country: India
facility: Dr.Vinay J. Clinic
city: Bangalore
country: India
facility: Sri Sai Health Care Center
city: Chennai
country: India
facility: Chandra Chest and Diabetes Care Center
city: Chennai
country: India
facility: Dr. Srinivasan Clinic
city: Chennai
country: India
facility: Vasavi Clinic
city: Chennai
country: India
facility: Sree Narayana Nursing Home
city: Chennai
country: India
facility: Adhiparasakthi Clinic
city: Chennai
country: India
facility: Sow-Krish Clinic
city: Chennai
country: India
facility: Javantika Clinic
city: Chennai
country: India
facility: Prime Family Medical Centre
city: Chennai
country: India
facility: Dr. U. V. Mohan Clinic
city: Chennai
country: India
facility: Dr. S. Nagrajan Clinic
city: Chennai
country: India
facility: Vcure Clinic
city: Chennai
country: India
facility: Dr. Sriram V. Clinic
city: Delhi
country: India
facility: Goel Clinic
city: Delhi
country: India
facility: Joshi Clinic
city: Delhi
country: India
facility: Sharma Clinic
city: Delhi
country: India
facility: Jain Clinic
city: Delhi
country: India
facility: Sanjeevan Clinic
city: Howrah
country: India
facility: Dr. Asoktaru Sengupta Clinic
city: Howrah
country: India
facility: Dr. Mridul Bera Clinic
city: Hyderabad
country: India
facility: Dr. Jagdish singh Clinic
city: Hyderabad
country: India
facility: Geetha Hospital
city: Hyderabad
country: India
facility: Maxcure Hospitals
city: Hyderabad
country: India
facility: City Clinic
city: Kolkata
country: India
facility: Healthy Lifestyle Clinic, Kolkata
city: Kolkata
country: India
facility: Dass Medical Hall
city: Kolkata
country: India
facility: Dr. Arabinda Halder Clinic
city: Kolkata
country: India
facility: Dr. Parinata Roy Clinic
city: Kolkata
country: India
facility: Dr. A. K. Chatterjee Clinic
city: Kolkata
country: India
facility: Dr. O. P. Sharma Clinic
city: Mumbai
country: India
facility: Qureshi Clinic
city: Mumbai
country: India
facility: Contractor Clinic
city: Mumbai
country: India
facility: Dhabolkar Clinic
city: Mumbai
country: India
facility: Bhulchandani Hospital
city: Mumbai
country: India
facility: Dr. S. Vikas Clinic
city: Mumbai
country: India
facility: Ajitkumar Clinic
city: Secunderabad
country: India
facility: Dr. A. Mahadev Clinic
city: Secunderabad
country: India
facility: Gayatri Clinic
city: Thane
country: India
facility: Boricha Clinic
city: Thane
country: India
facility: Devrukhar Clinic
city: Thane
country: India
facility: Pawar Clinic
city: Thane
country: India
facility: Thakkar Clinic
Study officials:
affiliation: Abbott Healthcare PVT. LTD.
name: Ganesh Kadhe, MD
role: STUDY_CHAIR
References: