Effect of Nutritional Supplementation on Nutritional Status & Rehospitalization in Malnourished Elderly Patients
- Conditions
- Malnutrition
- Interventions
- Dietary Supplement: Nutrient-dense drink
- Registration Number
- NCT06068816
- Lead Sponsor
- Indonesia University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- older patients (60-years or older)
- Malnourished or at risk of malnourished (based on Mini Nutritional Assessment score)
- Impaired kidney function (eGFR less than 30 ml/min/1.73 m2)
- Unwillingness to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutrient Dense Drink 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
- Primary Outcome Measures
Name Time Method Changes in carbohydrate intake in grams at baseline and week 12 Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes in Fat intake in grams at baseline and week 12 Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes of Energy in Kilocalories at baseline and week 12 Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes in Protein intake in grams at baseline and week 12 Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Changes in micronutrients intake in micrograms at baseline and week 12 Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
- Secondary Outcome Measures
Name Time Method Changes of Vitamin D level 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
Changes of Short Physical Performance Battery Score 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 performancesChanges of Mini Nutritional Status Score 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
Changes of Body Weight 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
Changes to Chair Stand Test 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 scoringChanges of Skeletal Muscle Mass Screening (Week 0) and week 12 Skeletal Muscle mass will be measured by Bioelectrical Impedance Analysis (BIA) recorded in Kg
Changes of Handgrip Strength Screening (Week 0) and week 12 Handgrip strength will be measured by a handgrip dynamometer (recorded in Kg)
Number of the Participants with Rehospitalization 3 months (12 weeks) Non-elective hospitalization will be recorded by medical history
Gait Speed 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
Trial Locations
- Locations (2)
Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital
🇮🇩Jakarta, Indonesia
Cipto Mangunkusumo National Hospital
🇮🇩Jakarta, Indonesia