Effect of Nutritional Supplementation on Nutritional Status & Rehospitalization in Malnourished Elderly Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel
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Treatment 1: nutrient-dense drinks on top of standard care
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Treatment 2: standard care only (reference)
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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.
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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.
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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.
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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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Changes of Energy in Kilocalories [at baseline, week 6, 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, week 6, 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, week 6, 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, week 6, 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, week 6, and week 12]
Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day)
Secondary Outcome Measures
- 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), Week 4, Week 6, Week 12]
Body weight will be measured in the fasted state to the nearest 0.1 kg with a calibrated digital scale
- Changes of Lean Body Mass [Screening (Week 0) and week 12]
Lean body mass will be measured by Bioelectrical Impedance Analysis (BIA)
- Changes of Short Physical Performance Battery Score [Screening (Week 0) and week 12]
Physical performance will be measured by Short Physical Performance Battery as well as individual gait speed in second. 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 Balance Test in second Scoring Held for 10 sec : 1 point Not held for 10 sec : 0 points Not attempted :0 points If 0 points, and Balance Tests 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 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
- Number of the Participants with Rehospitalization [3 months (12 weeks)]
Non-elective hospitalization will be recorded by medical history
Eligibility Criteria
Criteria
Inclusion Criteria:
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older patients (60-years or older)
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Malnourished or at risk of malnourished (based on Mini Nutritional Assessment score)
Exclusion Criteria:
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Impaired kidney function (eGFR less than 30 ml/min/1.73 m2)
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Unwillingness to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cipto Mangunkusumo National Hospital | Jakarta | Indonesia | 10430 | |
| 2 | Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital | Jakarta | Indonesia |
Sponsors and Collaborators
- Indonesia University
- 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 Chair: Rina Agustina, MD, PhD, Indonesia University
- 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 Director: Grace Wangge, MD, PhD, Monash University Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Prolansia01