Malnutrition
Conditions
Keywords
Malnutrition, Geriatric, Oral nutritional supplement
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
Interventions
DIETARY_SUPPLEMENTNutrient-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
Sponsors
Wageningen University
FrieslandCampina
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessment will be performed by blinded raters.
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 performances |
| Changes of Handgrip Strength | Screening (Week 0) and week 12 | Handgrip strength will be measured by a handgrip dynamometer (recorded in Kg) |
| 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 466 to 652 sec : 2 points If time is 362 to 465 sec: 3 points If time is less than 362 sec:4 points |
| 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 1670 sec or more: 1 points If chair stand time is 1370 to 1669 sec: 2 points If chair stand time is 1120 to 1369 sec: 3 points If chair stand time is 1119 sec or less: 4 points Score will be used for final SPPB scoring |
| Number of the Participants with Rehospitalization | 3 months (12 weeks) | Non-elective hospitalization will be recorded by medical history |
| Changes 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 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 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 of Skeletal Muscle Mass | Screening (Week 0) and week 12 | Skeletal Muscle mass will be measured by Bioelectrical Impedance Analysis (BIA) recorded in Kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Balance Test | 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 |
Countries
Indonesia
Outcome results
None listed