Nutrition Intervention in Older Adults at Risk of Malnutrition

NCT05682781 | Completed

• 1 other identifier: BL64
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

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.

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Measured in kg

  Baseline to 60 days

Secondary Outcomes (6)

• Malnutrition risk

  Baseline, Study Day 30 and Study Day 60

• Body mass index (BMI)

  Baseline, Study Day 30 and Study Day 60

• Mid-upper arm circumference

  Baseline, Study Day 30 and Study Day 60

• Change in body weight

  Baseline and Study Day 30

• Energy intake

  Baseline, Study Day 30 and Study Day 60

Study Arms (2)

Dietary Counseling

ACTIVE COMPARATOR

Other: Dietary Counseling

Dietary Counseling + Oral Nutritional Supplement

EXPERIMENTAL

Dietary Supplement: Oral Nutritional Supplement; Other: Dietary Counseling

Interventions

Oral Nutritional Supplement DIETARY_SUPPLEMENT

Oral Nutritional Supplement

Dietary Counseling + Oral Nutritional Supplement

Dietary Counseling OTHER

Dietary Counseling

Dietary Counseling; Dietary Counseling + Oral Nutritional Supplement

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (2)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

The Department of Internal Medicine, Faculty of Medicine, Thammasat University

Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Dietary Supplements; Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Zhongyuan Liu, RDN, MPH

  Abbott Nutrition Research & Development

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 12, 2023
• Study Start: March 9, 2023
• Primary Completion: February 29, 2024
• Study Completion: April 2, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

TH (2)