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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 : 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)

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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

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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

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
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Contact: Kristen DeLuca, MS,RD,LD 614-624-5455 kristen.deluca@abbott.com

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Locations
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India
Subramanyam's Day Care Center Recruiting
Bangalore, India, 560018
Hegde Multi Speciality Clinic Not yet recruiting
Bangalore, India, 560041
Dr. Prakash B. Clinic Not yet recruiting
Bangalore, India, 560058
Sunidhi Health Centre Recruiting
Bangalore, India, 560072
Shri Sharada Multi Specialty Hospital Not yet recruiting
Bangalore, India, 560076
Dr.Vinay J. Clinic Recruiting
Bangalore, India, 560091
Sri Sai Health Care Center Recruiting
Bangalore, India, 560100
Chandra Chest and Diabetes Care Center Recruiting
Chennai, India, 600001
Dr. Srinivasan Clinic Not yet recruiting
Chennai, India, 600001
Vasavi Clinic Recruiting
Chennai, India, 600007
Sree Narayana Nursing Home Recruiting
Chennai, India, 600011
Adhiparasakthi Clinic Not yet recruiting
Chennai, India, 600018
Saraswathi Clinic Not yet recruiting
Chennai, India, 600018
Sow-Krish Clinic Not yet recruiting
Chennai, India, 600020
Javantika Clinic Recruiting
Chennai, India, 600028
Prime Family Medical Centre Recruiting
Chennai, India, 600040
Dr. U. V. Mohan Clinic Recruiting
Chennai, India, 600050
Dr. S. Nagrajan Clinic Recruiting
Chennai, India, 600091
Vcure Clinic Recruiting
Chennai, India, 600100
Dr. Sriram V. Clinic Recruiting
Chennai, India, 600107
Krishnan Clinic Not yet recruiting
Delhi, India, 110015
Dr Naresh Chawla Clinic Not yet recruiting
Delhi, India, 110027
Khetrapal Clinic Not yet recruiting
Delhi, India, 110027
Malhotra Clinic Not yet recruiting
Delhi, India, 110027
Bhanot Clinic Not yet recruiting
Delhi, India, 110032
Goel Clinic Recruiting
Delhi, India, 110032
Jai Hospital Not yet recruiting
Delhi, India, 110034
Chandi Clinic Recruiting
Delhi, India, 110051
Joshi Clinic Recruiting
Delhi, India, 110051
Pahwa Clinic Not yet recruiting
Delhi, India, 110051
Rupoi Clinic Recruiting
Delhi, India, 110051
Shri Ram Singh & Heart Institute Not yet recruiting
Delhi, India, 110051
Sharma Clinic Recruiting
Delhi, India, 110053
Dayal Nursing Home Not yet recruiting
Delhi, India, 110085
Jain Clinic Recruiting
Delhi, India, 110091
Sanjeevan Clinic Recruiting
Delhi, India, 110092
Jeevan Jyoti Nursing Home Not yet recruiting
Delhi, India, 110095
Dr. Asoktaru Sengupta Clinic Recruiting
Howrah, India, 711101
Dr. Mridul Bera Clinic Not yet recruiting
Howrah, India, 711109
Dr. Jagdish singh Clinic Recruiting
Hyderabad, India, 500016
Geetha Hospital Not yet recruiting
Hyderabad, India, 500060
Maxcure Hospitals Recruiting
Hyderabad, India, 500081
City Clinic Recruiting
Hyderabad, India, 500082
GD Hospital & Diabetes Institute Not yet recruiting
Kolkata, India, 700013
Healthy Lifestyle Clinic, Kolkata Recruiting
Kolkata, India, 700014
Dass Medical Hall Not yet recruiting
Kolkata, India, 700017
Dr. Arabinda Halder Clinic Recruiting
Kolkata, India, 700063
Narayana Multispeciality Hospital Not yet recruiting
Kolkata, India, 700064
Dr. Parinata Roy Clinic Not yet recruiting
Kolkata, India, 700074
Dr. A. K. Chatterjee Clinic Recruiting
Kolkata, India, 700091
Salt Lake Clinic, Kolkata Recruiting
Kolkata, India, 700097
Dr. Suddhasatwa Ghosh Clinic Not yet recruiting
Kolkata, India, 700129
Dr. O. P. Sharma Clinic Recruiting
Kolkata, India, 743101
Qureshi Clinic Recruiting
Mumbai, India, 400016
Contractor Clinic Not yet recruiting
Mumbai, India, 400054
Dhabolkar Clinic Recruiting
Mumbai, India, 400056
Dave Cinic Not yet recruiting
Mumbai, India, 400062
Bhulchandani Hospital Recruiting
Mumbai, India, 400064
Dr. S. Vikas Clinic Recruiting
Mumbai, India, 400067
Ajitkumar Clinic Recruiting
Mumbai, India, 400071
Shah Clinic Not yet recruiting
Mumbai, India, 400080
Shah Clinic Not yet recruiting
Navi Mumbai, India, 400103
Seth Hospital Not yet recruiting
Navi Mumbai, India, 400703
Sons Clinic Not yet recruiting
Navi Mumbai, India, 400706
Dr. A. Mahadev Clinic Recruiting
Secunderabad, India, 500002
Dr. Raj Gopal Kishan Clinic Not yet recruiting
Secunderabad, India, 500015
Gayatri Clinic Recruiting
Secunderabad, India, 500055
Boricha Clinic Recruiting
Thane, India, 400601
Devrukhar Clinic Recruiting
Thane, India, 400605
Pawar Clinic Recruiting
Thane, India, 400606
Thakkar Clinic Recruiting
Thane, India, 400610
Sponsors and Collaborators
Abbott Nutrition
Investigators
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Study Chair: Ganesh Kadhe, MD Abbott Healthcare PVT. LTD.

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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

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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