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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline to 12 weeks
Measured weight kg
Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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