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NCT Number: NCT05682781

Nutrition Intervention in Older Adults at Risk of Malnutrition

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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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkoknoi, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Nutritional Supplement

Dietary Supplement

Oral Nutritional Supplement

Dietary Counseling

Other

Dietary Counseling

Primary outcomes

  1. Change in body weight

    Time frame: Baseline to 60 days

    Measured in kg

Secondary outcomes

  1. Malnutrition risk

    Time frame: Baseline, Study Day 30 and Study Day 60

    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.

  2. Body mass index (BMI)

    Time frame: Baseline, Study Day 30 and Study Day 60

    Weight (kg)/Height (m)2

  3. Mid-upper arm circumference

    Time frame: Baseline, Study Day 30 and Study Day 60

    Measured in cm

  4. Change in body weight

    Time frame: Baseline and Study Day 30

    Measured in kg

  5. Energy intake

    Time frame: Baseline, Study Day 30 and Study Day 60

    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.

  6. Nutrient intake

    Time frame: Baseline, Study Day 30 and Study Day 60

    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.

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Effects of Oral Nutritional Supplement With Dietary Counseling in Community Dwelling Older Adults at Risk of Malnutrition

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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