MalnutritionNHERCNCT03245047

The Nutritional Health for the Elderly Reference Centre Study (The NHERC Study)

A study testing Oral Nutritional Supplement with AN 777 and Oral Nutritional Supplement in people with Malnutrition, run by Abbott Nutrition at 4 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The prevalence of malnutrition among the elderly in Asia is high. The objective of this randomized, parallel, placebo controlled, double-blind study is to evaluate the effects of consuming an adult ONS plus dietary counseling (intervention group) for 180 days on nutritional status and unexpected hospital… Read more about this study

Who is it for?: Ages 65 to 110 years
Conditions the study is for: Malnutrition
What is being tested?: Oral Nutritional Supplement with AN 777 and Oral Nutritional Supplement
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 811 participants
Where: 4 sitesSingapore
Study dates: 30 Aug 2017to 10 Mar 2020
Phase: Interventional
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 65 to 110 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

Male or female participant aged ≥65 years.
Community-dweller, i.e. not staying in a residential intermediate and long-term care (ILTC) service institution.
Participant is being discharged home directly (applicable for hospital cohort).
Participant is community ambulant with or without aid.
Participant does not have any chronic disease(s) or has stable chronic disease(s) including hypertension, chronic obstructive pulmonary disease, and cardiovascular disease in the opinion of the Study Physician, at study entry
Participant has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board (IRB) and provided authorization prior to any participation in the study.

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Participants will be able to communicate and follow instructions.
Participant is able to consume food and beverages orally.
Participant has been identified as at risk of undernutrition as defined by Malnutrition Universal Screening Tool.
Participant is willing to refrain from taking non-study oral nutritional supplements including protein powder over the entire course of the study.
Participant is able and willing to follow study procedures and record data in diary and complete any forms or assessments needed throughout the study, with or without the help of the caregivers.

Who cannot join

Participant has been diagnosed with dementia according to medical records.
Participant has been diagnosed with type 1 or type 2 diabetes according to medical records. (Note: This includes participant with controlled diabetes.)
Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection) according to medical records.
Participant has been diagnosed with severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records.
Participant has been diagnosed with end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the screening according to medical records.
Participant has malignancy according to medical records.

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Participant has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
Participant is taking part in another study that has not been approved as a concomitant study by the study team.
Participant has been diagnosed or is known to be allergic or intolerant to milk products.
Participant has continuous ONS usage for 30 days prior to the screening.

Trial locations and contacts

4 sites in 1 country.

Singapore4 sites

Marine Parade Polyclinic
Singapore, 440080
Bedok Polyclinic
Singapore, 460212
Tampines Polyclinic
Singapore, 529203
Changi General Hospital
Singapore, 529889

Other trials in Singapore

About this study

Official title: A Prospective Randomized Double Blind Clinical Study to Determine the Clinical Impact of ONS in Community-dwelling Elderly

Read the detailed description

This randomized controlled trial will involve 800 elderly who are at risk of undernutrition (MUST score ≥ 1). Participants will be screened for eligibility. Recruitment will be at the polyclinic and in the inpatient ward prior to their discharge from the hospital. Participants will be randomized to intervention group vs. control group at the baseline visit at the clinical trial research unit where baseline measurements and baseline survey using the study specific questionnaires will be performed. Participants will be followed up prospectively at Day 30, Day 90, Day 180 (exit visit), and Day 360 (post-intervention follow-up visit). Repeated measures will be performed at the pre-defined time points. Intention-to-treat analysis comparing intervention group vs. control group will be performed to study the effect of ONS on primary composite outcome consisting of (i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period. The effect of ONS on nutritional status will be examined by comparing the biochemical and anthropometric measurements of intervention group vs. control group at Day 180. Other outcomes such as changes in functional assessment, nutritional knowledge levels, and quality of life will also be examined. There will be a follow up visit at Day 360.

Conditions: Malnutrition
Being tested: Oral Nutritional Supplement with AN 777, Oral Nutritional Supplement
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 with AN 777Dietary supplement
Oral Nutritional Supplement with AN 777, 2 servings a day
Oral Nutritional SupplementOther
Oral Nutritional Supplement, 2 servings a day

Study groups in NCT03245047
Study group	Role	What they receive
Intervention group	Experimental	Dietary Supplement: Oral Nutritional Supplement with AN777 Participants in the intervention group will be asked to consume two servings of oral nutritional supplement per day for 180 days. (Oral Consumption) Receives: Dietary Supplement: Oral Nutritional Supplement with AN 777
Control group	Placebo comparator	Participants in the control group will be asked to consume two servings of Oral nutritional supplement per day for 180 days.(Oral Consumption) Receives: Other: Oral Nutritional Supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary composite outcome consisting of change in body weight and unexpected hospital admission
(i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period (Death before any unexpected admission to the hospital will be counted as a hospitalization event)
Measured: baseline to Day 180

Secondary outcomes (2)

Fat mass and fat free mass
Fat mass and fat free mass in kilograms will be measured using Tanita MC-780
Measured: Baseline, 30 days, 90 days and 180 days]
Length of stay of unexpected hospital admission(s)
Unexpected admission to the hospital over 90-day and 180-day intervention periods
Measured: 90 days & 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 201710 Mar 2020

First posted10 Aug 2017
Study start30 Aug 2017
Primary completion10 Mar 2020
Study completion10 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MalnutritionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a prospective, randomized, placebo controlled, double-blind, parallel design, multi-center study. Eligible participants will be randomly allocated to one of two groups: oral nutritional supplement with dietary counseling group or placebo supplement with dietary counseling group. Randomization will be stratified by MUST malnutrition status (medium risk or high risk) and site of recruitment. All participants, including both recently discharged patients from the hospital or elderly recruited from the polyclinics.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 811 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03245047
Sponsor's protocol ID: BL35 (Part 2)
Acronym: NHERC
Status last verified: Mar 2021
First submitted: 1 Aug 2017
Last updated: 5 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chew STH, Tey SL, Yalawar M, Liu Z, Baggs G, How CH, Cheong M, Chow WL, Low YL, Huynh DTT, Tan NC. Prevalence and associated factors of sarcopenia in community-dwelling older adults at risk of malnutrition. BMC Geriatr. 2022 Dec 24;22(1):997. doi: 10.1186/s12877-022-03704-1.
PubMed 36564733
Chew STH, Tan NC, Cheong M, Oliver J, Baggs G, Choe Y, How CH, Chow WL, Tan CYL, Kwan SC, Husain FS, Low YL, Huynh DTT, Tey SL. Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition. Clin Nutr. 2021 Apr;40(4):1879-1892. doi: 10.1016/j.clnu.2020.10.015. Epub 2020 Oct 15.
PubMed 33268143

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malnutrition trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Double Blind Clinical Study to Determine the Clinical Impact of ONS in Community-dwelling Elderly
ClinicalTrials.gov ID: NCT03245047
Acronym / sponsor ID: NHERC / BL35 (Part 2)
Conditions: Malnutrition
Study type: Interventional
Recruitment status: Completed
Enrolment: 811 participants (actual)
Lead sponsor: Abbott NutritionIndustry (pharma, biotech, devices)
Collaborators: Changi General Hospital, SingHealth Polyclinics
Study start: 30 Aug 2017 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 10 Mar 2020 (actual)
First posted: 10 Aug 2017 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: This is a prospective, randomized, placebo controlled, double-blind, parallel design, multi-center study. Eligible participants will be randomly allocated to one of two groups: oral nutritional supplement with dietary counseling group or placebo supplement with dietary counseling group. Randomization will be stratified by MUST malnutrition status (medium risk or high risk) and site of recruitment. All participants, including both recently discharged patients from the hospital or elderly recruited from the polyclinics.

Arm	Type	Receives
Intervention group	Experimental	Dietary Supplement: Oral Nutritional Supplement with AN 777Dietary Supplement: Oral Nutritional Supplement with AN777 Participants in the intervention group will be asked to consume two servings of oral nutritional supplement per day for 180 days. (Oral Consumption)
Control group	Placebo comparator	Other: Oral Nutritional SupplementParticipants in the control group will be asked to consume two servings of Oral nutritional supplement per day for 180 days.(Oral Consumption)

Who may qualify

Ages: 65 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (11 listed)

Male or female participant aged ≥65 years.
Community-dweller, i.e. not staying in a residential intermediate and long-term care (ILTC) service institution.
Participant is being discharged home directly (applicable for hospital cohort).
Participant is community ambulant with or without aid.
Participant does not have any chronic disease(s) or has stable chronic disease(s) including hypertension, chronic obstructive pulmonary disease, and cardiovascular disease in the opinion of the Study Physician, at study entry

Key exclusion criteria (10 listed)

Participant has been diagnosed with dementia according to medical records.
Participant has been diagnosed with type 1 or type 2 diabetes according to medical records. (Note: This includes participant with controlled diabetes.)
Participant has any active infectious disease (such as tuberculosis, Hepatitis B or C, HIV infection) according to medical records.
Participant has been diagnosed with severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records.
Participant has been diagnosed with end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the screening according to medical records.

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 with AN 777Oral Nutritional Supplement with AN 777, 2 servings a day	Dietary supplement	Intervention group
Oral Nutritional SupplementOral Nutritional Supplement, 2 servings a day	Other	Control group

Primary outcome

Primary composite outcome consisting of change in body weight and unexpected hospital admission
Time frame: baseline to Day 180
(i) change in body weight from baseline to Day 180 or (ii) unexpected admission to the hospital over 180-day intervention period (Death before any unexpected admission to the hospital will be counted as a hospitalization event)

2 secondary outcomes

Fat mass and fat free mass
Time frame: Baseline, 30 days, 90 days and 180 days]
Length of stay of unexpected hospital admission(s)
Time frame: 90 days & 180 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
Derived from this study: PubMed 36564733Chew STH, Tey SL, Yalawar M, Liu Z, Baggs G, How CH, Cheong M, Chow WL, Low YL, Huynh DTT, Tan NC. Prevalence and associated factors of sarcopenia in community-dwelling older adults at risk of malnutrition. BMC Geriatr. 2022 Dec 24;22(1):997. doi: 10.1186/s12877-022-03704-1.
Derived from this study: PubMed 33268143Chew STH, Tan NC, Cheong M, Oliver J, Baggs G, Choe Y, How CH, Chow WL, Tan CYL, Kwan SC, Husain FS, Low YL, Huynh DTT, Tey SL. Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition. Clin Nutr. 2021 Apr;40(4):1879-1892. doi: 10.1016/j.clnu.2020.10.015. Epub 2020 Oct 15.
Individual participant dataSharing planned: No

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Development and Testing of Nutritional Algorithms (NACHO)
Nutrition Poor, Nutritional Deficiency
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
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RecruitingObservational study
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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.

Agnes Siew Ling Tey, Ph.D. study chair

Abbott Nutrition Research & Development

Samuel TH Chew, MB.BCh.BAO principal investigator

Changi General Hospital

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oral Nutritional Supplement with AN 777 and Oral Nutritional Supplement in people with Malnutrition, run by Abbott Nutrition at 4 sites in Singapore.

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 11 inclusion and 10 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: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Singapore. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary composite outcome consisting of change in body weight and unexpected hospital admission (time frame: baseline to Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03245047, which also lists 2 linked publications.

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 5 Mar 2021.