Benefits of Standard ONS in Indian Adults

NCT ID: NCT03713463

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-04

Study Completion Date

2020-09-06

Brief Summary

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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.

Detailed Description

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Conditions

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Poor Nutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oral Nutritional Supplement (ONS)

2 servings per day ONS

Oral Nutritional Supplement (ONS)

Intervention Type OTHER

Per standard of care (SOC)

Interventions

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Oral Nutritional Supplement (ONS)

Per standard of care (SOC)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ganesh Kadhe, MD

Role: STUDY_CHAIR

Abbott Healthcare PVT. LTD.

Locations

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Subramanyam's Day Care Center

Bangalore, , India

Site Status

Sunidhi Health Centre

Bangalore, , India

Site Status

Dr.Vinay J. Clinic

Bangalore, , India

Site Status

Sri Sai Health Care Center

Bangalore, , India

Site Status

Chandra Chest and Diabetes Care Center

Chennai, , India

Site Status

Dr. Srinivasan Clinic

Chennai, , India

Site Status

Vasavi Clinic

Chennai, , India

Site Status

Sree Narayana Nursing Home

Chennai, , India

Site Status

Adhiparasakthi Clinic

Chennai, , India

Site Status

Sow-Krish Clinic

Chennai, , India

Site Status

Javantika Clinic

Chennai, , India

Site Status

Prime Family Medical Centre

Chennai, , India

Site Status

Dr. U. V. Mohan Clinic

Chennai, , India

Site Status

Dr. S. Nagrajan Clinic

Chennai, , India

Site Status

Vcure Clinic

Chennai, , India

Site Status

Dr. Sriram V. Clinic

Chennai, , India

Site Status

Goel Clinic

Delhi, , India

Site Status

Joshi Clinic

Delhi, , India

Site Status

Sharma Clinic

Delhi, , India

Site Status

Jain Clinic

Delhi, , India

Site Status

Sanjeevan Clinic

Delhi, , India

Site Status

Dr. Asoktaru Sengupta Clinic

Howrah, , India

Site Status

Dr. Mridul Bera Clinic

Howrah, , India

Site Status

Dr. Jagdish singh Clinic

Hyderabad, , India

Site Status

Geetha Hospital

Hyderabad, , India

Site Status

Maxcure Hospitals

Hyderabad, , India

Site Status

City Clinic

Hyderabad, , India

Site Status

Healthy Lifestyle Clinic, Kolkata

Kolkata, , India

Site Status

Dass Medical Hall

Kolkata, , India

Site Status

Dr. Arabinda Halder Clinic

Kolkata, , India

Site Status

Dr. Parinata Roy Clinic

Kolkata, , India

Site Status

Dr. A. K. Chatterjee Clinic

Kolkata, , India

Site Status

Dr. O. P. Sharma Clinic

Kolkata, , India

Site Status

Qureshi Clinic

Mumbai, , India

Site Status

Contractor Clinic

Mumbai, , India

Site Status

Dhabolkar Clinic

Mumbai, , India

Site Status

Bhulchandani Hospital

Mumbai, , India

Site Status

Dr. S. Vikas Clinic

Mumbai, , India

Site Status

Ajitkumar Clinic

Mumbai, , India

Site Status

Dr. A. Mahadev Clinic

Secunderabad, , India

Site Status

Gayatri Clinic

Secunderabad, , India

Site Status

Boricha Clinic

Thāne, , India

Site Status

Devrukhar Clinic

Thāne, , India

Site Status

Pawar Clinic

Thāne, , India

Site Status

Thakkar Clinic

Thāne, , India

Site Status

Countries

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India

Other Identifiers

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DA18

Identifier Type: -

Identifier Source: org_study_id

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