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

University of Indonesia (UI)

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Nutrient-dense drink

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06068816

Prolansia01

Details and patient eligibility

About

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.

Full 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

Enrollment: 105 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

105 participants in 2 patient groups

Nutrient Dense Drink

Experimental group

Description:

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

Treatment:

Dietary Supplement: Nutrient-dense drink

Standard Care

No Intervention group

Description:

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