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Completed

NCT Number: NCT06068816

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

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

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo National Hospital, Jakarta, Indonesia

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About this study

  • Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel
  • Treatment 1: nutrient-dense drinks on top of standard care
  • Treatment 2: standard care only (reference)
  • 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.
  • 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.
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nutrient-dense drink

Dietary 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

Primary outcomes

  1. Changes of Energy in Kilocalories

    Time frame: at baseline and week 12

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

  2. Changes in Protein intake in grams

    Time frame: at baseline and week 12

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

  3. Changes in Fat intake in grams

    Time frame: at baseline and week 12

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

  4. Changes in carbohydrate intake in grams

    Time frame: at baseline and week 12

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

  5. Changes in micronutrients intake in micrograms

    Time frame: at baseline and week 12

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

Secondary outcomes

  1. Changes of Mini Nutritional Status Score

    Time frame: at screening (Week 0) and week 12

    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

  2. Changes of Vitamin D level

    Time frame: Screening (Week 0) and week 12

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

  3. Changes of Body Weight

    Time frame: Screening (week 0) and Week 12

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

  4. Changes of Skeletal Muscle Mass

    Time frame: Screening (Week 0) and week 12

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

  5. Changes of Short Physical Performance Battery Score

    Time frame: Screening (Week 0) and week 12

    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

  6. Changes of Handgrip Strength

    Time frame: Screening (Week 0) and week 12

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

  7. Number of the Participants with Rehospitalization

    Time frame: 3 months (12 weeks)

    Non-elective hospitalization will be recorded by medical history

  8. Gait Speed

    Time frame: Screening (Week 0) and week 12

    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

  9. Changes to Chair Stand Test

    Time frame: Screening (Week 0) and week 12

    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

Other outcomes

  1. Balance Test

    Time frame: Screening (Week 0) and week 12

    Outcome recorded in seconds

    A. Side-by-side-stand

    Held for 10 sec ❒ 1 point If participant did not attempt test or failed, circle why:

    Not held for 10 sec ❒ 0 points Tried but unable 1 Not attempted ❒ 0 points Participant could not hold position unassisted 2 If 0 points, end Balance Tests Number of seconds held if instructions less than 10 sec: . sec

    B. Semi-Tandem Stand Held for 10 sec ❒ 1 point Not held for 10 sec ❒ 0 points Not attempted ❒ 0 points (circle reason above) If 0 points, end Balance Tests Number of seconds held if less than 10 sec: . sec

    C. Tandem Stand Held for 10 sec ❒ 2 points Held for 3 to 9.99 sec ❒ 1 point Held for < than 3 sec ❒ 0 points Not attempted ❒ 0 points (circle reason above) Number of seconds held if less than 10 sec: . sec

    Not reported as Secondary outcome but results will be used to calculate SPPB score

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • FrieslandCampina
  • Wageningen University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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