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

NCT ID: NCT06068816

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-10-15

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.

Detailed 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

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nutrient Dense Drink

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

Group Type: EXPERIMENTAL

Nutrient-dense drink

Intervention Type: 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

Standard Care

Standard care comprising:

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wageningen University

OTHER

Sponsor Role: collaborator

FrieslandCampina

INDUSTRY

Sponsor Role: collaborator

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Siti Setiati

Professor of Geriatric Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Siti Setiati, MD (Internist Geriatrician),PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Prof.Dr.Ing. Lisette CPGM de Groot, PhD

Role: STUDY_CHAIR

Wageningen University the Netherlands

Esthika Dewiasty, MD (Internist Geriatrician), MSc

Role: STUDY_DIRECTOR

Universitas Indonesia, PhD candidate at Wageningen University

Sjors Verlaan, PhD

Role: STUDY_DIRECTOR

FrieslandCampina

Rahmi Istanti, BSc, MPH

Role: STUDY_DIRECTOR

Indonesia University

Locations

Cipto Mangunkusumo National Hospital

Jakarta, , Indonesia

Comprehensive Geriatric Clinic, Cipto Mangunkusumo Hospital

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

Prolansia01

Identifier Type: -

Identifier Source: org_study_id