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Benefits of Standard ONS in Indian Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03713463
Recruitment Status : Terminated (COVID-19 enrollment challenges)
First Posted : October 19, 2018
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Study Description
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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.

Condition or disease Intervention/treatment
Poor Nutrition Other: Oral Nutritional Supplement (ONS)

Study Design
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : September 6, 2020
Actual Study Completion Date : September 6, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Oral Nutritional Supplement (ONS)
2 servings per day ONS
 Other: Oral Nutritional Supplement (ONS)
Per standard of care (SOC)


Outcome Measures
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Primary Outcome Measures :
  1. Weight [ Time Frame: Baseline to 12 weeks ]
    Measured weight kg


Secondary Outcome Measures :
  1. Hand Grip [ Time Frame: Baseline to 12 weeks ]
    Dynamometer

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Out-patient healthcare clinics across India
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713463


Locations
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Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Ganesh Kadhe, MD Abbott Healthcare PVT. LTD.
More Information
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Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03713463    
Other Study ID Numbers: DA18
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders