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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
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
Cipto Mangunkusumo National Hospital
Jakarta, Indonesia
Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital
Jakarta, Indonesia
Changes of Energy in Kilocalories
Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: at baseline and week 12
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
Time frame: 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
Time frame: Screening (Week 0) and week 12
Changes of Body Weight
Body weight will be measured in the fasted state to the nearest 0.1 kg with a calibrated digital scale
Time frame: 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
Time frame: 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
Time frame: Screening (Week 0) and week 12
Changes of Handgrip Strength
Handgrip strength will be measured by a handgrip dynamometer (recorded in Kg)
Time frame: Screening (Week 0) and week 12
Number of the Participants with Rehospitalization
Non-elective hospitalization will be recorded by medical history
Time frame: 3 months (12 weeks)
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
Time frame: 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
Time frame: Screening (Week 0) and week 12
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