MalnutritionNCT05682781
Nutrition Intervention in Older Adults at Risk of Malnutrition
A study testing Oral Nutritional Supplement and Dietary Counseling in people with Malnutrition, run by Abbott Nutrition at 2 sites in Thailand.
Trial summary
Thailand is one of the fastest aging countries and older adults are at greater risk of having inadequate nutrient intake and malnutrition (undernutrition). In the community setting, malnutrition has been linked to low muscle mass, sarcopenia, increased incidence of disability and functional impairments. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Oral Nutritional Supplement and Dietary Counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesThailand
- Study dates
- 9 Mar 2023to 2 Apr 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participant aged ≥60 years at risk of undernutrition.
- Community-dweller.
- Participant is community ambulant.
- Participant does not have any chronic disease(s) or has stable chronic disease(s) at study entry.
- Participant voluntarily signed and dated on an IRB approved informed consent form (ICF) and provided authorization prior to study participation.
- Participant is able to communicate and follow instructions.
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- Participant is able to consume food and beverages orally.
- Participant is willing to refrain from taking non-study oral nutritional supplements.
- Participant is able and willing to follow study procedures and record data in diary and complete forms or assessments as needed.
Who cannot join
- Participant diagnosed with type 1 or type 2 diabetes.
- Participant has active infectious disease.
- Participant has been diagnosed with severe gastrointestinal disorders.
- Participant has been diagnosed with advanced renal disease or end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the baseline visit.
- Participant has active malignancy within the last five years, or is in current treatment for malignancy.
- Participant has any condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
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- Participant is taking part in another study that has not been approved as a concomitant study.
- Participant has disorder or other conditions, that may interfere with study product consumption or compliance with study protocol procedures.
- Participant has been diagnosed or known to be allergic or intolerant to milk products.
- Participant has continuous oral nutritional supplement usage for 30 days prior to the baseline visit.
- Participant has been taking herbals, dietary supplements, or medications during the past 30 days prior to the baseline visit that could profoundly affect body weight or appetite.
- Participant has clinically significant ascites, pleural effusion, edema, or dehydration
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
The Department of Internal Medicine, Faculty of Medicine, Thammasat University
Pathum Thani, 12120
About this study
Official title: Effects of Oral Nutritional Supplement With Dietary Counseling in Community Dwelling Older Adults at Risk of Malnutrition
Thailand is one of the fastest aging countries and older adults are at greater risk of having inadequate nutrient intake and malnutrition (undernutrition). In the community setting, malnutrition has been linked to low muscle mass, sarcopenia, increased incidence of disability and functional impairments. The objective of this prospective, multicenter, randomized controlled, open-label, parallel-design study is to determine the effects of an oral nutritional supplement with dietary counseling on body weight, in comparison with dietary counseling alone, in community dwelling older adults at risk of malnutrition.
- Conditions
- Malnutrition
- Being tested
- Oral Nutritional Supplement, Dietary Counseling
- 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 SupplementDietary supplement
Oral Nutritional Supplement
Dietary CounselingOther
Dietary Counseling
| Study group | Role | What they receive |
|---|---|---|
| Dietary Counseling | Active comparator | Not described Receives: Other: Dietary Counseling |
| Dietary Counseling + Oral Nutritional Supplement | Experimental | Not described Receives: Dietary Supplement: Oral Nutritional Supplement; Other: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured in kg
Measured: Baseline to 60 days
Secondary outcomes (6)
Malnutrition risk
Malnutrition Universal Screening Tool is a widely used screening tool for malnutrition. It classifies participants into one of three nutrition status categories: low risk/score = 0, medium risk/score = 1, and high risk/score ≥ 2. Minimum value = 0, Maximum value = 6. Higher score indicates worse outcome, i.e., increased risk of malnutrition.
Measured: Baseline, Study Day 30 and Study Day 60
Body mass index (BMI)
Weight (kg)/Height (m)2
Measured: Baseline, Study Day 30 and Study Day 60
Mid-upper arm circumference
Measured in cm
Measured: Baseline, Study Day 30 and Study Day 60
Change in body weight
Measured in kg
Measured: Baseline and Study Day 30
Energy intake
24-Hour Dietary Recall: Researcher-led interview on food and drink intake the previous day. Nutrient analysis will be performed using a dietary analysis program.
Measured: Baseline, Study Day 30 and Study Day 60
Nutrient intake
24-Hour Dietary Recall: Researcher-led interview on food and drink intake the previous day. Nutrient analysis will be performed using a dietary analysis program.
Measured: Baseline, Study Day 30 and Study Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start9 Mar 2023
- Primary completion29 Feb 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhongyuan Liu, RDN, MPH, Study chair, Abbott Nutrition Research & Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682781
- Sponsor's protocol ID
- BL64
- Status last verified
- Jul 2024
- First submitted
- 4 Jan 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nutritional Supplement With Dietary Counseling in Community Dwelling Older Adults at Risk of Malnutrition
- ClinicalTrials.gov ID
- NCT05682781
- Acronym / sponsor ID
- BL64
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 12 Jan 2023 (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.
Thailand is one of the fastest aging countries and older adults are at greater risk of having inadequate nutrient intake and malnutrition (undernutrition). In the community setting, malnutrition has been linked to low muscle mass, sarcopenia, increased incidence of disability and functional impairments. The objective of this prospective, multicenter, randomized controlled, open-label, parallel-design study is to determine the effects of an oral nutritional supplement with dietary counseling on body weight, in comparison with dietary counseling alone, in community dwelling older adults at risk of malnutrition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Counseling | Active comparator | Other: Dietary Counseling |
| Dietary Counseling + Oral Nutritional Supplement | Experimental | Dietary Supplement: Oral Nutritional Supplement, Other: Dietary Counseling |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female participant aged ≥60 years at risk of undernutrition.
- Community-dweller.
- Participant is community ambulant.
- Participant does not have any chronic disease(s) or has stable chronic disease(s) at study entry.
- Participant voluntarily signed and dated on an IRB approved informed consent form (ICF) and provided authorization prior to study participation.
Key exclusion criteria (12 listed)
- Participant diagnosed with type 1 or type 2 diabetes.
- Participant has active infectious disease.
- Participant has been diagnosed with severe gastrointestinal disorders.
- Participant has been diagnosed with advanced renal disease or end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the baseline visit.
- Participant has active malignancy within the last five years, or is in current treatment for malignancy.
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 SupplementOral Nutritional Supplement | Dietary supplement | Dietary Counseling + Oral Nutritional Supplement |
| Dietary CounselingDietary Counseling | Other | Dietary Counseling, Dietary Counseling + Oral Nutritional Supplement |
Primary outcome
Change in body weight
Time frame: Baseline to 60 days
Measured in kg
6 secondary outcomes
Malnutrition risk
Time frame: Baseline, Study Day 30 and Study Day 60
Body mass index (BMI)
Time frame: Baseline, Study Day 30 and Study Day 60
Mid-upper arm circumference
Time frame: Baseline, Study Day 30 and Study Day 60
Change in body weight
Time frame: Baseline and Study Day 30
Energy intake
Time frame: Baseline, Study Day 30 and Study Day 60
Nutrient intake
Time frame: Baseline, Study Day 30 and Study Day 60
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 1 Aug 2024.
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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.
Zhongyuan Liu, RDN, MPH study chair
Abbott Nutrition Research & Development
2 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 and Dietary Counseling in people with Malnutrition, run by Abbott Nutrition at 2 sites in Thailand.
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 9 inclusion and 12 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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 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?
Change in body weight (time frame: Baseline to 60 days). 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 1 Aug 2024.