Nutrition Intervention in Older Adults at Risk of Malnutrition

Abbott

Status: Completed

Conditions: Malnutrition

Treatments: Other: Dietary Counseling; Dietary Supplement: Oral Nutritional Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT05682781

BL64

Details and patient eligibility

About

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.

Enrollment: 196 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups

Dietary Counseling

Active Comparator group

Treatment:

Other: Dietary Counseling

Dietary Counseling + Oral Nutritional Supplement

Experimental group

Treatment:

Dietary Supplement: Oral Nutritional Supplement

Other: Dietary Counseling