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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. 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 : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Tracking Information
First Submitted Date October 18, 2018
First Posted Date October 19, 2018
Last Update Posted Date September 16, 2019
Actual Study Start Date July 4, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2018)
Weight [ Time Frame: Baseline to 12 weeks ]
Measured weight kg
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03713463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 14, 2018)
  • Hand Grip [ Time Frame: Baseline to 12 weeks ]
    Dynamometer
  • 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)
Original Secondary Outcome Measures
 (submitted: October 18, 2018)
  • Hand Grip [ Time Frame: Baseline to 12 weeks ]
    Dynamometer
  • Quality of Life [ Time Frame: Baseline to 12 weeks ]
    WHOQOL-BREF Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Benefits of Standard ONS in Indian Adults
Official Title An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Out-patient healthcare clinics across India
Condition Poor Nutrition
Intervention Other: Oral Nutritional Supplement (ONS)
Per standard of care (SOC)
Study Groups/Cohorts Oral Nutritional Supplement (ONS)
2 servings per day ONS
Intervention: Other: Oral Nutritional Supplement (ONS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 18, 2018)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kristen DeLuca, MS,RD,LD 614-624-5455 kristen.deluca@abbott.com
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03713463
Other Study ID Numbers DA18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abbott Nutrition
Study Sponsor Abbott Nutrition
Collaborators Not Provided
Investigators
Study Chair: Ganesh Kadhe, MD Abbott Healthcare PVT. LTD.
PRS Account Abbott Nutrition
Verification Date September 2019