Poor NutritionNCT03713463
Benefits of Standard ONS in Indian Adults
An observational study of Poor Nutrition, run by Abbott Nutrition at 45 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Poor Nutrition
- What is being tested?
- Oral Nutritional Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- How many people
- 59 participants
- Where
- 45 sitesIndia
- Study dates
- 4 Jul 2019to 6 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out-patient healthcare clinics across India
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
India45 sites
Subramanyam's Day Care Center
Bangalore, 560018
Sunidhi Health Centre
Bangalore, 560072
Dr.Vinay J. Clinic
Bangalore, 560091
Sri Sai Health Care Center
Bangalore, 560100
Chandra Chest and Diabetes Care Center
Chennai, 600001
Dr. Srinivasan Clinic
Chennai, 600001
Vasavi Clinic
Chennai, 600007
Sree Narayana Nursing Home
Chennai, 600011
Adhiparasakthi Clinic
Chennai, 600018
Sow-Krish Clinic
Chennai, 600020
Javantika Clinic
Chennai, 600028
Prime Family Medical Centre
Chennai, 600040
Dr. U. V. Mohan Clinic
Chennai, 600050
Dr. S. Nagrajan Clinic
Chennai, 600091
Vcure Clinic
Chennai, 600100
Dr. Sriram V. Clinic
Chennai, 600107
Goel Clinic
Delhi, 110032
Joshi Clinic
Delhi, 110051
Sharma Clinic
Delhi, 110053
Jain Clinic
Delhi, 110091
Sanjeevan Clinic
Delhi, 110092
Dr. Asoktaru Sengupta Clinic
Howrah, 711101
Dr. Mridul Bera Clinic
Howrah, 711109
Dr. Jagdish singh Clinic
Hyderabad, 500016
Geetha Hospital
Hyderabad, 500060
Maxcure Hospitals
Hyderabad, 500081
City Clinic
Hyderabad, 500082
Healthy Lifestyle Clinic, Kolkata
Kolkata, 700014
Dass Medical Hall
Kolkata, 700017
Dr. Arabinda Halder Clinic
Kolkata, 700063
Dr. Parinata Roy Clinic
Kolkata, 700074
Dr. A. K. Chatterjee Clinic
Kolkata, 700091
Dr. O. P. Sharma Clinic
Kolkata, 743101
Qureshi Clinic
Mumbai, 400016
Contractor Clinic
Mumbai, 400054
Dhabolkar Clinic
Mumbai, 400056
Bhulchandani Hospital
Mumbai, 400064
Dr. S. Vikas Clinic
Mumbai, 400067
Ajitkumar Clinic
Mumbai, 400071
Dr. A. Mahadev Clinic
Secunderabad, 500002
Gayatri Clinic
Secunderabad, 500055
Boricha Clinic
Thane, 400601
Devrukhar Clinic
Thane, 400605
Pawar Clinic
Thane, 400606
Thakkar Clinic
Thane, 400610
About this study
Official title: An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
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.
- Conditions
- Poor Nutrition
- Being tested
- Oral Nutritional Supplement (ONS)
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional Supplement (ONS)Other
Per standard of care (SOC)
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement (ONS) | 2 servings per day ONS Receives: Other: Oral Nutritional Supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured weight kg
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Hand Grip
Dynamometer
Measured: Baseline to 12 weeks
Quality of Life (QoL)
World Health Organization QOL-BREF Questionnaire; 4 Domain scores scaled in a positive direction (very dissatisfied - very satisfied)
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start4 Jul 2019
- Primary completion6 Sep 2020
- Study completion6 Sep 2020
Why it stopped: COVID-19 enrollment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ganesh Kadhe, MD, Study chair, Abbott Healthcare PVT. LTD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713463
- Sponsor's protocol ID
- DA18
- Status last verified
- Jan 2022
- First submitted
- 18 Oct 2018
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multicenter Study to Evaluate the Benefits of Regular Intake of Standard ONS in Indian Adults
- ClinicalTrials.gov ID
- NCT03713463
- Acronym / sponsor ID
- DA18
- Conditions
- Poor Nutrition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 enrollment challenges
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 6 Sep 2020 (actual)
- Study completion
- 6 Sep 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement (ONS) | – | Other: Oral Nutritional Supplement (ONS)2 servings per day ONS |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out-patient healthcare clinics across India
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional Supplement (ONS)Per standard of care (SOC) | Other | Oral Nutritional Supplement (ONS) |
Primary outcome
Weight
Time frame: Baseline to 12 weeks
Measured weight kg
2 secondary outcomes
Hand Grip
Time frame: Baseline to 12 weeks
Quality of Life (QoL)
Time frame: Baseline to 12 weeks
Results and safety
The study was stopped early (reason given: COVID-19 enrollment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesh Kadhe, MD study chair
Abbott Healthcare PVT. LTD.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Nutrition, run by Abbott Nutrition at 45 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 enrollment challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.