Nutrition Intervention in Older Adults at Risk of Malnutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2024-04-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dietary Counseling

Group Type ACTIVE_COMPARATOR

Dietary Counseling

Intervention Type OTHER

Dietary Counseling

Dietary Counseling + Oral Nutritional Supplement

Group Type EXPERIMENTAL

Oral Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

Oral Nutritional Supplement

Dietary Counseling

Intervention Type OTHER

Dietary Counseling

Interventions

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Oral Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

Dietary Counseling

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No