Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03713463
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

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)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 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
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Group/Cohort Intervention/treatment
Oral Nutritional Supplement (ONS)
2 servings per day ONS
Other: Oral Nutritional Supplement (ONS)
Per standard of care (SOC)




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Kristen DeLuca, MS,RD,LD 614-624-5455 kristen.deluca@abbott.com

  Show 71 Study Locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
Layout table for investigator information
Study Chair: Ganesh Kadhe, MD Abbott Healthcare PVT. LTD.

Layout table for additonal information
Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03713463     History of Changes
Other Study ID Numbers: DA18
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Nutrition Disorders