Clinical trial NCT05682781: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2023-01-12
Enrollment: 196
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to 60 days
Secondary outcomes:
measure: Malnutrition risk
timeFrame: Baseline, Study Day 30 and Study Day 60
measure: Body mass index (BMI)
timeFrame: Baseline, Study Day 30 and Study Day 60
measure: Mid-upper arm circumference
timeFrame: Baseline, Study Day 30 and Study Day 60
measure: Change in body weight
timeFrame: Baseline and Study Day 30
measure: Energy intake
timeFrame: Baseline, Study Day 30 and Study Day 60
measure: Nutrient intake
timeFrame: Baseline, Study Day 30 and Study Day 60
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
city: Pathumthani
country: Thailand
facility: The Department of Internal Medicine, Faculty of Medicine, Thammasat University
Study officials:
affiliation: Abbott Nutrition Research & Development
name: Zhongyuan Liu, RDN, MPH
role: STUDY_CHAIR
References: