Nutrition Intervention in Older Adults at Risk of Malnutrition

Effects of Oral Nutritional Supplement With Dietary Counseling in Community Dwelling Older Adults at Risk of Malnutrition

Thailand is one of the fastest aging countries and older adults are at greater risk of having inadequate nutrient intake and malnutrition (undernutrition). In the community setting, malnutrition has been linked to low muscle mass, sarcopenia, increased incidence of disability and functional impairments. The objective of this prospective, multicenter, randomized controlled, open-label, parallel-design study is to determine the effects of an oral nutritional supplement with dietary counseling on body weight, in comparison with dietary counseling alone, in community dwelling older adults at risk of malnutrition.

Study Overview

• Status: Active, not recruiting
• Conditions: Malnutrition
• Intervention / Treatment: Other: Dietary Counseling; Dietary supplement: Oral Nutritional Supplement

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mei Qi Mak, BSc; Phone Number: +65 6801 6272; Email: meiqi.mak@abbott.com

Study Locations

• Thailand
  • Pathumthani, Thailand, 12120
    • The Department of Internal Medicine, Faculty of Medicine, Thammasat University
    • Principal Investigator: Sanit Wichansawakun
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital, Mahidol University
      • Principal Investigator: Weerasak Muangpaisarn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female participant aged ≥60 years at risk of undernutrition.
2. Community-dweller.
3. Participant is community ambulant.
4. Participant does not have any chronic disease(s) or has stable chronic disease(s) at study entry.
5. Participant voluntarily signed and dated on an IRB approved informed consent form (ICF) and provided authorization prior to study participation.
6. Participant is able to communicate and follow instructions.
7. Participant is able to consume food and beverages orally.
8. Participant is willing to refrain from taking non-study oral nutritional supplements.
9. Participant is able and willing to follow study procedures and record data in diary and complete forms or assessments as needed.

Exclusion Criteria:

1. Participant diagnosed with type 1 or type 2 diabetes.
2. Participant has active infectious disease.
3. Participant has been diagnosed with severe gastrointestinal disorders.
4. Participant has been diagnosed with advanced renal disease or end stage organ or pre-terminal diseases or acute myocardial infarction within the last 30 days from the baseline visit.
5. Participant has active malignancy within the last five years, or is in current treatment for malignancy.
6. Participant has any condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
7. Participant is taking part in another study that has not been approved as a concomitant study.
8. Participant has disorder or other conditions, that may interfere with study product consumption or compliance with study protocol procedures.
9. Participant has been diagnosed or known to be allergic or intolerant to milk products.
10. Participant has continuous oral nutritional supplement usage for 30 days prior to the baseline visit.
11. Participant has been taking herbals, dietary supplements, or medications during the past 30 days prior to the baseline visit that could profoundly affect body weight or appetite.
12. Participant has clinically significant ascites, pleural effusion, edema, or dehydration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietary Counseling	Other: Dietary Counseling; Dietary Counseling
Experimental: Dietary Counseling + Oral Nutritional Supplement	Other: Dietary Counseling; Dietary Counseling; Dietary supplement: Oral Nutritional Supplement; Oral Nutritional Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Measured in kg	Baseline to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)	Weight (kg)/Height (m)2	Baseline, Study Day 30 and Study Day 60
Mid-upper arm circumference	Measured in cm	Baseline, Study Day 30 and Study Day 60
Change in body weight	Measured in kg	Baseline and Study Day 30
Energy intake	24-Hour Dietary Recall: Researcher-led interview on food and drink intake the previous day. Nutrient analysis will be performed using a dietary analysis program.	Baseline, Study Day 30 and Study Day 60
Nutrient intake	24-Hour Dietary Recall: Researcher-led interview on food and drink intake the previous day. Nutrient analysis will be performed using a dietary analysis program.	Baseline, Study Day 30 and Study Day 60
Malnutrition risk	Malnutrition Universal Screening Tool is a widely used screening tool for malnutrition. It classifies participants into one of three nutrition status categories: low risk/score = 0, medium risk/score = 1, and high risk/score ≥ 2. Minimum value = 0, Maximum value = 6. Higher score indicates worse outcome, i.e., increased risk of malnutrition.	Baseline, Study Day 30 and Study Day 60

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Zhongyuan Liu, RDN, MPH, Abbott Nutrition Research & Development

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): March 20, 2024
• Study Completion (Estimated): March 20, 2024

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: BL64

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No