Effect of Nutritional Supplementation on Nutritional Status & Rehospitalization in Malnourished Elderly Patients

Study Overview
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Brief Summary
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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
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Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel Treatment 1: nutrient-dense drinks on top of standard care Treatment 2: standard care only (reference) 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. 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. 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. 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

Official Title
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The Effect of 12 Weeks of Nutritional Supplementation on Nutritional Intake and Status in Older Outpatients With Malnutrition Risk

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Nutrient-dense drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrient Dense Drink<br>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<br>* 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<br>|
| No Intervention: Standard Care<br>Standard care comprising: Standard care only will be provided nutritional counseling to achieve a better nutritional state | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Energy in Kilocalories | Dietary intake will be measured using 3-day dietary food records, 2 weekdays and 1 weekend day) | at baseline, week 6, 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) | at baseline, week 6, 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) | at baseline, week 6, 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) | at baseline, week 6, 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) | at baseline, week 6, and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Screening (week 0), Week 4, Week 6, Week 12 | 
| Changes of Lean Body Mass | Lean body mass will be measured by Bioelectrical Impedance Analysis (BIA) | Screening (Week 0) and week 12 | 
| Changes of Short Physical Performance Battery Score | 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 466 to 652 sec : 2 points If time is 362 to 465 sec: 3 points If time is less than 362 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 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 Scoring for complete Short Physical Performance Battery Category Scores : 0 - 6 points : poor performance 7-9 points : moderate performance 10-12 points : good performances | Screening (Week 0) and week 12 | 
| Changes of Handgrip Strength | Handgrip strength will be measured by a handgrip dynamometer | Screening (Week 0) and week 12 | 
| Number of the Participants with Rehospitalization | Non-elective hospitalization will be recorded by medical history | 3 months (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Geriatric, Oral nutritional supplement