AzTrials
AzTrials

MalnutritionNCT06068816

Effect of Nutritional Supplementation on Nutritional Status & Rehospitalization in Malnourished Elderly Patients

A study testing Nutrient-dense drink in people with Malnutrition, run by Universitas Indonesia at 2 sites in Indonesia.

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 primary outcome is the mean difference in energy and protein as well as a selection of micronutrients (calcium, vitamin D, and Vitamin B12) after 12 weeks of intervention between standard care plus nutritional supplementation vs standard care. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Malnutrition
What is being tested?
Nutrient-dense drink
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
2 sitesIndonesia
Study dates
15 Jul 2022to 15 Oct 2023
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

  • older patients (60-years or older)
  • Malnourished or at risk of malnourished (based on Mini Nutritional Assessment score)

Who cannot join

  • Impaired kidney function (eGFR less than 30 ml/min/1.73 m2)
  • Unwillingness to participate

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Cipto Mangunkusumo National Hospital

    Jakarta, 10430

  • Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital

    Jakarta

Other trials in Indonesia

About this study

Official title: The Effect of 12 Weeks of Nutritional Supplementation on Nutritional Intake and Status in Older Outpatients With Malnutrition Risk

The primary outcome is the mean difference in energy and protein as well as a selection of micronutrients (calcium, vitamin D, and Vitamin B12) after 12 weeks of intervention between standard care plus nutritional supplementation vs standard care.

The secondary outcomes are body weight, nutritional status, body composition, physical performance, vitamin D level, and nonelective hospitalization

Read more

The Study Hypothesize:

The hypothesize that outpatients who receive nutrient-dense drinks (NDD) will have increased body weight, better nutritional status, better body composition, higher vitamin D level, better physical performance and reduced non-elective hospitalization than those receiving standard care after 12 weeks of intervention.

Read the detailed description
  1. Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel
  2. Treatment 1: nutrient-dense drinks on top of standard care
  3. Treatment 2: standard care only (reference)
  4. Location and time study: Geriatric outpatient clinic and internal medicine outpatient clinic in Cipto Mangunkusumo National Hospital Jakarta. The study will be conducted on July 2022 to October 2023.
  5. Study subject: elderly outpatients (aged 60 years old or more) who visit outpatient clinics will be screened for their eligibility as participants of this study.
  6. Sample Size: sample size for each group is 41 participants per group (for two groups a total of 82 participants). To anticipate a dropout of 20% a minimum of 98 participants (rounded to 100 participants in total) is the minimum sample size of our study.
  7. Data collection : Energy and nutrient intake, particularly protein calcium, vitamin D, and vitamin B12, Nutritional status based on full form Mini Nutritional Assessment, Vitamin D level, lean body mass (using Bioelectrical Impedance Analysis), physical performance will be measured by Shor Physical Performance Battery, handgrip strength, medical history, data on the demographic status and clinical data will be retrieved from the medical record and the attending physicians, body weight and anthropometric measurements, intervention: Nutrient Dense-Drink + Standard Care
Conditions
Malnutrition
Being tested
Nutrient-dense drink
Keywords
Malnutrition, Geriatric, 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.

  • Nutrient-dense drinkDietary supplement

    a nutrient-dense drink developed by FrieslandCampina in line with the European Society for Clinical Nutrition and Metabolism guidelines for the dietary management of older malnourished patients

Study groups in NCT06068816
Study groupRoleWhat they receive
Nutrient Dense DrinkExperimentalExperimental: Nutrient-dense drink Nutrient-dense drink on top of standard care * 200 kcal * 15 grams of (whey) protein, 8 grams of fat, and 17 grams of carbohydrates including only 0.2 g lactose * 400 IU vitamin D, 250 mg Ca, 10-20 % of the other vitamins/minerals Servings : • 100 ml water for dissolving 46 g of the served powder
Receives: Dietary Supplement: Nutrient-dense drink
Standard CareNo interventionStandard care comprising: Standard care only will be provided nutritional counseling to achieve a better nutritional state

What is being measured

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

  1. Changes of Energy in Kilocalories

    Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)

    Measured: at baseline and week 12

  2. Changes in Protein intake in grams

    Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)

    Measured: at baseline and week 12

  3. Changes in Fat intake in grams

    Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)

    Measured: at baseline and week 12

  4. Changes in carbohydrate intake in grams

    Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)

    Measured: at baseline and week 12

  5. Changes in micronutrients intake in micrograms

    Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)

    Measured: at baseline and week 12

Secondary outcomes (9)

  1. Changes of Mini Nutritional Status Score

    The nutritional status will be measured by full form mini nutritional assessment, individuals can be divided in 3 groups using threshold values of <17 for malnourished, 17-23,5 for at risk of malnutrition and ≥ 24 for normal nutritional status with a maximum total score of 30 points

    Measured: at screening (Week 0) and week 12

  2. Changes of Vitamin D level

    Vitamin D level as a parameter of nutritional status will be measured by the direct competitive chemiluminescence microparticle immunoassay (CMIA) method

    Measured: Screening (Week 0) and week 12

  3. Changes of Body Weight

    Body weight will be measured in the fasted state to the nearest 0.1 kg with a calibrated digital scale

    Measured: Screening (week 0) and Week 12

  4. Changes of Skeletal Muscle Mass

    Skeletal Muscle mass will be measured by Bioelectrical Impedance Analysis (BIA) recorded in Kg

    Measured: Screening (Week 0) and week 12

  5. Changes of Short Physical Performance Battery Score

    Physical performance will be measured by Short Physical Performance Battery, which is measured by scores from Gait speed, chair stand test, and balance test

    Scoring for complete Short Physical Performance Battery

    Category Scores :

    0 - 6 points : poor performance 7-9 points : moderate performance 10-12 points : good performances

    Measured: Screening (Week 0) and week 12

  6. Changes of Handgrip Strength

    Handgrip strength will be measured by a handgrip dynamometer (recorded in Kg)

    Measured: Screening (Week 0) and week 12

  7. Number of the Participants with Rehospitalization

    Non-elective hospitalization will be recorded by medical history

    Measured: 3 months (12 weeks)

  8. Gait Speed

    Outcome recorded in seconds for Baseline, and the Changes (Delta) in 12 weeks

    Additionally, results will be converted into score, which will be used for final SPPB scoring

    3 meter walk: The score is, If time is more than 6''52 sec : 1 point If time is 4"66 to 6"52 sec : 2 points If time is 3"62 to 4"65 sec: 3 points If time is less than 3"62 sec:4 points

    Measured: Screening (Week 0) and week 12

  9. Changes to Chair Stand Test

    Outcome recorded in seconds for Baseline, and the Changes (Delta) in 12 weeks

    Additionally, results will be converted into score, which will be used for final SPPB scoring

    Participant unable to complete 5 chair stands or completes stands in >60 sec : 0 points If chair stand time is 16"70 sec or more: 1 points If chair stand time is 13"70 to 16"69 sec: 2 points If chair stand time is 11"20 to 13"69 sec: 3 points If chair stand time is 11"19 sec or less: 4 points

    Score will be used for final SPPB scoring

    Measured: Screening (Week 0) and week 12

Timeline

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

  1. First posted5 Oct 2023
  2. Study start15 Jul 2022
  3. Primary completion15 Oct 2023
  4. Study completion15 Oct 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized to the treatment. Subjects will receive either standard care or standard care plus nutrients dense drinks. Randomization will be done by a third party who is not involved in the study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06068816
Sponsor's protocol ID
Prolansia01
Status last verified
Aug 2024
First submitted
9 Mar 2022
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All findings of this study will be published in an international open-access journal. Please contact us if any researchers need our individual participant data.

Questions about this trial

What is this clinical trial studying?

A study testing Nutrient-dense drink in people with Malnutrition, run by Universitas Indonesia at 2 sites in Indonesia.

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 2 inclusion and 2 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 27 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 Indonesia. 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?

Changes of Energy in Kilocalories (time frame: at baseline and week 12). The study lists 5 primary outcomes in all. 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 NCT06068816.

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 27 Aug 2024.

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