Clinical trial NCT06068816: Effect of Nutritional Supplementation on Nutritional Status & Rehospitalization in Malnourished Elderly Patients
Official title: The Effect of 12 Weeks of Nutritional Supplementation on Nutritional Intake and Status in Older Outpatients With Malnutrition Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Geriatric
Oral nutritional supplement
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Wageningen University
name: FrieslandCampina
First posted: 2023-10-05
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Energy in Kilocalories
timeFrame: at baseline and week 12
measure: Changes in Protein intake in grams
timeFrame: at baseline and week 12
measure: Changes in Fat intake in grams
timeFrame: at baseline and week 12
measure: Changes in carbohydrate intake in grams
timeFrame: at baseline and week 12
measure: Changes in micronutrients intake in micrograms
timeFrame: at baseline and week 12
Secondary outcomes:
measure: Changes of Mini Nutritional Status Score
timeFrame: at screening (Week 0) and week 12
measure: Changes of Vitamin D level
timeFrame: Screening (Week 0) and week 12
measure: Changes of Body Weight
timeFrame: Screening (week 0) and Week 12
measure: Changes of Skeletal Muscle Mass
timeFrame: Screening (Week 0) and week 12
measure: Changes of Short Physical Performance Battery Score
timeFrame: Screening (Week 0) and week 12
measure: Changes of Handgrip Strength
timeFrame: Screening (Week 0) and week 12
measure: Number of the Participants with Rehospitalization
timeFrame: 3 months (12 weeks)
measure: Gait Speed
timeFrame: Screening (Week 0) and week 12
measure: Changes to Chair Stand Test
timeFrame: Screening (Week 0) and week 12
Other outcomes:
measure: Balance Test
timeFrame: Screening (Week 0) and week 12
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
city: Jakarta
country: Indonesia
facility: Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital
Study officials:
affiliation: Indonesia University
name: Prof. Siti Setiati, MD (Internist Geriatrician),PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University the Netherlands
name: Prof.Dr.Ing. Lisette CPGM de Groot, PhD
role: STUDY_CHAIR
affiliation: Universitas Indonesia, PhD candidate at Wageningen University
name: Esthika Dewiasty, MD (Internist Geriatrician), MSc
role: STUDY_DIRECTOR
affiliation: FrieslandCampina
name: Sjors Verlaan, PhD
role: STUDY_DIRECTOR
affiliation: Indonesia University
name: Rahmi Istanti, BSc, MPH
role: STUDY_DIRECTOR
References: