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

NCT06068816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-08-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Wageningen University

    collaborator OTHER

  • FrieslandCampina

    collaborator INDUSTRY

  • Indonesia University

    lead OTHER

Principal Investigators

  • Prof. Siti Setiati, MD (Internist Geriatrician),PhD · Indonesia University

  • Prof.Dr.Ing. Lisette CPGM de Groot, PhD · Wageningen University the Netherlands

  • Esthika Dewiasty, MD (Internist Geriatrician), MSc · Universitas Indonesia, PhD candidate at Wageningen University

  • Sjors Verlaan, PhD · FrieslandCampina

  • Rahmi Istanti, BSc, MPH · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2023-10-15
Completion
2023-10-15

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06068816 on ClinicalTrials.gov