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| Name | Class |
|---|---|
| Wageningen University | OTHER |
| FrieslandCampina | INDUSTRY |
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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.
Study Design: Randomized Controlled Trial, Randomized and controlled intervention trial with 2 treatments in parallel
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrient Dense Drink | Experimental | Experimental: Nutrient-dense drink Nutrient-dense drink on top of standard care
Servings : • 100 ml water for dissolving 46 g of the served powder |
|
| Standard Care | No Intervention | Standard care comprising: Standard care only will be provided nutritional counseling to achieve a better nutritional state |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrient-dense drink | Dietary Supplement | 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 |
| 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 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 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 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 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 and week 12 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Balance Test | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Siti Setiati, MD (Internist Geriatrician),PhD | Indonesia University | Principal Investigator |
| Prof.Dr.Ing. Lisette CPGM de Groot, PhD | Wageningen University the Netherlands | Study Chair |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo National Hospital | Jakarta | 10430 | Indonesia | |||
| Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital |
All findings of this study will be published in an international open-access journal. Please contact us if any researchers need our individual participant data.
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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Outcomes assessment will be performed by blinded raters.
| 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) and Week 12 |
| Changes of Skeletal Muscle Mass | Skeletal Muscle mass will be measured by Bioelectrical Impedance Analysis (BIA) recorded in Kg | 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 | Screening (Week 0) and week 12 |
| Changes of Handgrip Strength | Handgrip strength will be measured by a handgrip dynamometer (recorded in Kg) | 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) |
| 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 | 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 | Screening (Week 0) and week 12 |
| Screening (Week 0) and week 12 |
| Jakarta |
| Indonesia |