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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06068816
• Other study ID #: Prolansia01
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo National Hospital	Jakarta
Indonesia	Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital	Jakarta

Sponsors (3)

Lead Sponsor	Collaborator
Indonesia University	FrieslandCampina, Wageningen University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Changes of Lean Body Mass	Lean body mass will be measured by Bioelectrical Impedance Analysis (BIA)	Screening (Week 0) and week 12
Secondary	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 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	Screening (Week 0) and week 12
Secondary	Changes of Handgrip Strength	Handgrip strength will be measured by a handgrip dynamometer	Screening (Week 0) and week 12
Secondary	Number of the Participants with Rehospitalization	Non-elective hospitalization will be recorded by medical history	3 months (12 weeks)