AzTrials
AzTrials

MalnutritionNCT04911712

The Effectiveness of a High-Protein Liquid Dietary Supplementation

A study testing a hospital formula of normal protein liquid diet supplementation and a hospital formula of high protein liquid food supplementation in people with Malnutrition and Nutritional Status, run by MARCELLUS SIMADIBRATA at 1 site 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

This study was a double-blind randomized controlled trial conducted to assess the effectiveness of high protein liquid dietary supplementation in malnourished hospitalized patients. The patients were assessed for their nutritional status based on ESPEN 2015 criteria. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Malnutrition, Nutritional Status, Hospital
What is being tested?
a hospital formula of normal protein liquid diet supplementation and a hospital formula of high protein liquid food supplementation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteIndonesia
Study dates
25 Mar 2019to 31 Dec 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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects aged ≥ 18 years old to 60 years old
  • Malnutrition hospitalized patient based on European Society for Clinical Nutrition and Metabolism (ESPEN) 2015 criteria
  • Agreed to participate

Who cannot join

  • Malignancy
  • Chronic kidney disease stage III-V
  • Decompensated hepatic cirrhosis
  • Allergic to milk or lactose intolerance
  • Could not be randomised and participate in this study by clinical judgement

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Faculty of Medicine, Universitas Indonesia

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: The Effectiveness of a High-Protein Liquid Dietary Supplementation in Improving Nutritional Status of Malnourished Patients in Hospital Care: a Preliminary Study

This study was a double-blind randomized controlled trial conducted to assess the effectiveness of high protein liquid dietary supplementation in malnourished hospitalized patients. The patients were assessed for their nutritional status based on ESPEN 2015 criteria. Patients who experienced malnutrition will be divided into 2 groups, namely the control group which was given a normal protein liquid diet, while the intervention group was given high protein liquid diet supplementation as much as 2 bottles (200 mL) per day for 7-10 days. Furthermore, the nutritional status of the patient was assessed.

Being tested
a hospital formula of normal protein liquid diet supplementation, a hospital formula of high protein liquid food supplementation
Keywords
Malnutrition, high-protein diet, nutritional status, hospitals, hand strength, body mass index, nutrition assessment, preliminary data
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • a hospital formula of normal protein liquid diet supplementationDietary supplement

    group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL)

  • a hospital formula of high protein liquid food supplementationDietary supplement

    group 2 (intervention group) will get a hospital formula of high protein liquid food supplementation (60 grams per 1000 mL) as much as 2 bottles (each bottle contains 200 mL)

Study groups in NCT04911712
Study groupRoleWhat they receive
Randomly selected malnourished patients for normal protein liquid diet supplementationActive comparatorRandomly selected malnourished patients for normal protein liquid diet supplementation
Receives: Dietary Supplement: a hospital formula of normal protein liquid diet supplementation
Randomly selected Malnourished patients with high protein liquid diet supplementationExperimentalMalnourished patients with high protein liquid diet supplementation
Receives: Dietary Supplement: a hospital formula of high protein liquid food supplementation

What is being measured

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

  1. Right handgrip strength

    Handgrip strength in kg based on sex and age

    Measured: Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm

  2. Adult malnutrition classification according to the WHO

    The classification of Adult malnutrition according to the WHO based on BMI which categorized into (mild,moderate or severe)

    Measured: the classification of malnutrition is assessed at day 10 of dietary supplementation in each arm

  3. Nutritional status based on Subjective Global Assessment (SGA)

    the Nutritional status based on Subjective Global Assessment (SGA). Group A is classified as Normal/ well-nourished. Group B is classified as Mild-Moderate nutrition. Group C is classified as Severe malnutrition.

    Measured: All SGA assesment is done at day 10 of dietary supplementation in each arm

Timeline

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

  1. First posted3 Jun 2021
  2. Study start25 Mar 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

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
a Preliminary Study
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04911712
Sponsor's protocol ID
KET-313/UN2.F1/ETIK
Status last verified
May 2021
First submitted
1 Apr 2021
Last updated
3 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meijers JM, van Bokhorst-de van der Schueren MA, Schols JM, Soeters PB, Halfens RJ. Defining malnutrition: mission or mission impossible? Nutrition. 2010 Apr;26(4):432-40. doi: 10.1016/j.nut.2009.06.012. Epub 2009 Dec 1.

    PubMed 19954929

  • Allard JP, Keller H, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Vesnaver E, Davidson B, Teterina A, Lou W. Malnutrition at Hospital Admission-Contributors and Effect on Length of Stay: A Prospective Cohort Study From the Canadian Malnutrition Task Force. JPEN J Parenter Enteral Nutr. 2016 May;40(4):487-97. doi: 10.1177/0148607114567902. Epub 2015 Jan 26.

    PubMed 25623481

  • Alvarez-Hernandez J, Planas Vila M, Leon-Sanz M, Garcia de Lorenzo A, Celaya-Perez S, Garcia-Lorda P, Araujo K, Sarto Guerri B; PREDyCES researchers. Prevalence and costs of malnutrition in hospitalized patients; the PREDyCES Study. Nutr Hosp. 2012 Jul-Aug;27(4):1049-59. doi: 10.3305/nh.2012.27.4.5986.

    PubMed 23165541

  • Schindler K, Pernicka E, Laviano A, Howard P, Schutz T, Bauer P, Grecu I, Jonkers C, Kondrup J, Ljungqvist O, Mouhieddine M, Pichard C, Singer P, Schneider S, Schuh C, Hiesmayr M; NutritionDay Audit Team. How nutritional risk is assessed and managed in European hospitals: a survey of 21,007 patients findings from the 2007-2008 cross-sectional nutritionDay survey. Clin Nutr. 2010 Oct;29(5):552-9. doi: 10.1016/j.clnu.2010.04.001.

    PubMed 20434820

  • Lim SL, Ong KC, Chan YH, Loke WC, Ferguson M, Daniels L. Malnutrition and its impact on cost of hospitalization, length of stay, readmission and 3-year mortality. Clin Nutr. 2012 Jun;31(3):345-50. doi: 10.1016/j.clnu.2011.11.001. Epub 2011 Nov 26.

    PubMed 22122869

  • Garber AK, Mauldin K, Michihata N, Buckelew SM, Shafer MA, Moscicki AB. Higher calorie diets increase rate of weight gain and shorten hospital stay in hospitalized adolescents with anorexia nervosa. J Adolesc Health. 2013 Nov;53(5):579-84. doi: 10.1016/j.jadohealth.2013.07.014. Epub 2013 Sep 17.

    PubMed 24054812

  • WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3.

    PubMed 14726171

  • Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9.

    PubMed 25799486

  • Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.

    PubMed 3820522

  • Huynh DT, Devitt AA, Paule CL, Reddy BR, Marathe P, Hegazi RA, Rosales FJ. Effects of oral nutritional supplementation in the management of malnutrition in hospital and post-hospital discharged patients in India: a randomised, open-label, controlled trial. J Hum Nutr Diet. 2015 Aug;28(4):331-43. doi: 10.1111/jhn.12241. Epub 2014 May 9.

    PubMed 24809429

Questions about this trial

What is this clinical trial studying?

A study testing a hospital formula of normal protein liquid diet supplementation and a hospital formula of high protein liquid food supplementation in people with Malnutrition and Nutritional Status, run by MARCELLUS SIMADIBRATA at 1 site 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 3 inclusion and 5 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Right handgrip strength (time frame: Handgrip strength is assessed at day 10 of dietary administration supplementation in each arm). The study lists 3 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 NCT04911712, which also lists 10 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 3 Jun 2021.

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