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

NCT06068816 | Completed

• 1 other identifier: Prolansia01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Malnutrition

Keywords

Malnutrition; Geriatric; Oral nutritional supplement

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (9)

• Changes of Mini Nutritional Status Score

  at screening (Week 0) and week 12

• Changes of Vitamin D level

  Screening (Week 0) and week 12

• Changes of Body Weight

  Screening (week 0) and Week 12

• Changes of Skeletal Muscle Mass

  Screening (Week 0) and week 12

• Changes of Short Physical Performance Battery Score

  Screening (Week 0) and week 12

Other Outcomes (1)

• Balance Test

  Screening (Week 0) and week 12

Study Arms (2)

Nutrient Dense Drink

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Standard care comprising: Standard care only will be provided nutritional counseling to achieve a better nutritional state

Interventions

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

Nutrient Dense Drink

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older patients (60-years or older)
• Malnourished or at risk of malnourished (based on Mini Nutritional Assessment score)

You may not qualify if:

• Impaired kidney function (eGFR less than 30 ml/min/1.73 m2)
• Unwillingness to participate

Sponsors & Collaborators

• Indonesia University: lead
• Wageningen University: collaborator
• FrieslandCampina: collaborator

Study Sites (2)

Cipto Mangunkusumo National Hospital

Jakarta, 10430, Indonesia

Location

Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessment will be performed by blinded raters.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Geriatric Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: October 5, 2023
• Study Start: July 15, 2022
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)