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

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Nutrient-dense drink

Detailed Description

1. Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel

   1. Treatment 1: nutrient-dense drinks on top of standard care
   2. Treatment 2: standard care only (reference)
2. 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.
3. 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.
4. 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.
5. 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

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 10430
    • Cipto Mangunkusumo National Hospital
  • Jakarta, Indonesia
    • Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrient Dense Drink; Experimental: 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	Dietary supplement: Nutrient-dense drink; 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
No Intervention: Standard Care; Standard care comprising: Standard care only will be provided nutritional counseling to achieve a better nutritional state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Energy in Kilocalories	Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)	at baseline and week 12
Changes in Protein intake in grams	Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)	at baseline and week 12
Changes in Fat intake in grams	Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)	at baseline and week 12
Changes in carbohydrate intake in grams	Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)	at baseline and week 12
Changes in micronutrients intake in micrograms	Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)	at baseline and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at screening (Week 0) and week 12
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	Screening (Week 0) and week 12
Number of the Participants with Rehospitalization	Non-elective hospitalization will be recorded by medical history	3 months (12 weeks)
Changes of Body Weight	Body weight will be measured in the fasted state to the nearest 0.1 kg with a calibrated digital scale	Screening (week 0) and Week 12
Changes of Skeletal Muscle Mass	Skeletal Muscle mass will be measured by Bioelectrical Impedance Analysis (BIA) recorded in Kg	Screening (Week 0) and week 12
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	Screening (Week 0) and week 12
Changes of Handgrip Strength	Handgrip strength will be measured by a handgrip dynamometer (recorded in Kg)	Screening (Week 0) and week 12
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	Screening (Week 0) and week 12
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	Screening (Week 0) and week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance Test	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	Screening (Week 0) and week 12

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Wageningen University; FrieslandCampina
• Investigators: Principal Investigator: Prof. Siti Setiati, MD (Internist Geriatrician),PhD, Indonesia University; Study Chair: Prof.Dr.Ing. Lisette CPGM de Groot, PhD, Wageningen University the Netherlands; Study Director: Esthika Dewiasty, MD (Internist Geriatrician), MSc, Universitas Indonesia, PhD candidate at Wageningen University; Study Director: Sjors Verlaan, PhD, FrieslandCampina; Study Director: Rahmi Istanti, BSc, MPH, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Malnutrition; Geriatric; Oral nutritional supplement
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: Prolansia01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No