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Nutrition Intervention in Older Adults at Risk of Malnutrition

Primary Purpose

Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Oral Nutritional Supplement
Dietary Counseling
Sponsored by
Abbott Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female participant aged ≥60 years at risk of undernutrition. Community-dweller. Participant is community ambulant. Participant does not have any chronic disease(s) or has stable chronic disease(s) at study entry. Participant voluntarily signed and dated on an IRB approved informed consent form (ICF) and provided authorization prior to study participation. Participant is able to communicate and follow instructions. Participant is able to consume food and beverages orally. Participant is willing to refrain from taking non-study oral nutritional supplements. Participant is able and willing to follow study procedures and record data in diary and complete forms or assessments as needed. Exclusion Criteria: Participant diagnosed with type 1 or type 2 diabetes. Participant has active infectious disease. Participant has been diagnosed with severe gastrointestinal disorders. 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. Participant has active malignancy within the last five years, or is in current treatment for malignancy. Participant has any condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study. Participant is taking part in another study that has not been approved as a concomitant study. Participant has disorder or other conditions, that may interfere with study product consumption or compliance with study protocol procedures. Participant has been diagnosed or known to be allergic or intolerant to milk products. Participant has continuous oral nutritional supplement usage for 30 days prior to the baseline visit. 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. Participant has clinically significant ascites, pleural effusion, edema, or dehydration

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting
  • The Department of Internal Medicine, Faculty of Medicine, Thammasat UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dietary Counseling

Dietary Counseling + Oral Nutritional Supplement

Arm Description

Outcomes

Primary Outcome Measures

Change in body weight
Measured in kg

Secondary Outcome Measures

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.
Body mass index (BMI)
Weight (kg)/Height (m)2
Mid-upper arm circumference
Measured in cm
Change in body weight
Measured in kg
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.
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.

Full Information

First Posted
January 4, 2023
Last Updated
July 7, 2023
Sponsor
Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT05682781
Brief Title
Nutrition Intervention in Older Adults at Risk of Malnutrition
Official Title
Effects of Oral Nutritional Supplement With Dietary Counseling in Community Dwelling Older Adults at Risk of Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary Counseling
Arm Type
Active Comparator
Arm Title
Dietary Counseling + Oral Nutritional Supplement
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Nutritional Supplement
Intervention Description
Oral Nutritional Supplement
Intervention Type
Other
Intervention Name(s)
Dietary Counseling
Intervention Description
Dietary Counseling
Primary Outcome Measure Information:
Title
Change in body weight
Description
Measured in kg
Time Frame
Baseline to 60 days
Secondary Outcome Measure Information:
Title
Malnutrition risk
Description
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.
Time Frame
Baseline, Study Day 30 and Study Day 60
Title
Body mass index (BMI)
Description
Weight (kg)/Height (m)2
Time Frame
Baseline, Study Day 30 and Study Day 60
Title
Mid-upper arm circumference
Description
Measured in cm
Time Frame
Baseline, Study Day 30 and Study Day 60
Title
Change in body weight
Description
Measured in kg
Time Frame
Baseline and Study Day 30
Title
Energy intake
Description
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.
Time Frame
Baseline, Study Day 30 and Study Day 60
Title
Nutrient intake
Description
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.
Time Frame
Baseline, Study Day 30 and Study Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participant aged ≥60 years at risk of undernutrition. Community-dweller. Participant is community ambulant. Participant does not have any chronic disease(s) or has stable chronic disease(s) at study entry. Participant voluntarily signed and dated on an IRB approved informed consent form (ICF) and provided authorization prior to study participation. Participant is able to communicate and follow instructions. Participant is able to consume food and beverages orally. Participant is willing to refrain from taking non-study oral nutritional supplements. Participant is able and willing to follow study procedures and record data in diary and complete forms or assessments as needed. Exclusion Criteria: Participant diagnosed with type 1 or type 2 diabetes. Participant has active infectious disease. Participant has been diagnosed with severe gastrointestinal disorders. 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. Participant has active malignancy within the last five years, or is in current treatment for malignancy. Participant has any condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study. Participant is taking part in another study that has not been approved as a concomitant study. Participant has disorder or other conditions, that may interfere with study product consumption or compliance with study protocol procedures. Participant has been diagnosed or known to be allergic or intolerant to milk products. Participant has continuous oral nutritional supplement usage for 30 days prior to the baseline visit. 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. Participant has clinically significant ascites, pleural effusion, edema, or dehydration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Qi Mak, BSc
Phone
+65 6801 6272
Email
meiqi.mak@abbott.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongyuan Liu, RDN, MPH
Organizational Affiliation
Abbott Nutrition Research & Development
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
The Department of Internal Medicine, Faculty of Medicine, Thammasat University
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Nutrition Intervention in Older Adults at Risk of Malnutrition

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