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Clinical Trials/NCT03713463
NCT03713463
Terminated
Not Applicable

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

Abbott Nutrition45 sites in 1 country59 target enrollmentJuly 4, 2019
ConditionsPoor Nutrition

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Poor Nutrition
Sponsor
Abbott Nutrition
Enrollment
59
Locations
45
Primary Endpoint
Weight
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 4, 2019
End Date
September 6, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Weight

Time Frame: Baseline to 12 weeks

Measured weight kg

Secondary Outcomes

  • Hand Grip(Baseline to 12 weeks)
  • Quality of Life (QoL)(Baseline to 12 weeks)

Study Sites (45)

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