The Effects of Continuous Intake of ONS on the Nutritional Status of Taiwanese Elderly

NCT04857463 | Completed

• 1 other identifier: N202011065
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

Past studies have pointed out that adequate intake of calories and protein in the elderly can deferred sarcopenia and debilitating conditions. Therefore, this study intends to use oral nutrition as a way of nutritional supplements, without affecting the subjects' normal meal intake, and supplements with snacks It is expected that there will be benefits in protein and muscle synthesis. However, the palatability of oral nutritional products will affect the effectiveness of nutritional supplements. Therefore, this test provides nutrients that are easy for the subjects to ingest with a variety of flavors, in order to achieve the test calories and protein needs. In order to investigate and compare the nutritional status, serum zinc and vitamin D status in healthy (MUST score 0) elderly and at risk of malnutrition elderly, we recruited healthy elderlies in the nursing home.

Conditions

Malnutrition Elderly

Keywords

Sarcopenia, Oral nutritional supplement, elderly people, nutritional education, malnutrition risk

Outcome Measures

Primary Outcomes (7)

• Blood biochemical value

  blood cell analysis, liver function test (AST/ALT), blood sugar, triglycerides, nutritional indicators (serum albumin), kidney function (urea nitrogen, creatinine), vitamin D, zinc, etc

  at the start of the experiment and at the 6th and 12th week

• Blood pressure

  measure systolic and diastolic blood pressure.

  at the start of the experiment and at the 6th and 12th week

• Body position measurement

  height, weight, waist-to-hip ratio, body mass index, etc.

  at the start of the experiment and at the 6th and 12th week

• Body composition

  Use a body fat machine to measure muscle mass, fat mass and water content.

  at the start of the experiment and at the 6th and 12th week

• Muscle strength test

  measure 6m walking speed, grip strength measurement, etc.

  at the start of the experiment and at the 6th and 12th week

• Diet pattern

  Evaluate the 24-hour recall method and Three-day dietary record

  at the start of the experiment and at the 6th and 12th week

• Quality of life and health status

  Use the quality of life questionnaire (SF-36) to evaluate the quality of life and health status

  at the start of the experiment and at the 6th and 12th week

Study Arms (3)

Nutritional supplement drink

EXPERIMENTAL

Nutritional supplement, this group receives a nutritional supplement for a period of 12 weeks.

Other: Nutritional supplement drink

Nutritional education

PLACEBO COMPARATOR

Qualified clinical dietitians provide regular nutrition education and ensure the effectiveness of nutrition education

Other: Nutritional education

Healthy control

NO INTERVENTION

No intervention was done to this group, only blood collection, physical performance and anthropometric assessment were done.

Interventions

Nutritional supplement drink OTHER

At the intervention period (0th to 12th week of the experiment), In addition to nutrition and health education, subjects were provided with 2 bottles of commercially available oral nutritional supplements (Meiji Mei Balance, Meiji Co., Ltd., Tokyo, Japan) every day, between lunch and dinner and before bedtime.

Nutritional supplement drink

Nutritional education OTHER

At the intervention period (0th to 12th week of the experiment) , subjects will be given regular nutrition education by a qualified clinical dietitian to ensure the effectiveness of nutrition education, in order for the nutrition education group to benefit from participating in this trial, the subjects will also be provided with the same nutritional products after the trial

Nutritional education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age \>65 years old (regardless of gender)
• Malnutrition risk judgment: Subjects were assessed as moderate and high malnutrition risk with the malnutrition risk screening tool MUST (Malnutrition Universal Screening Tool)

You may not qualify if:

• \. chronic diseases such as diabetes, end stage of chronic kidney disease, cancer.

Sponsors & Collaborators

• Taipei Medical University: lead
• Meiji Co., Ltd.: collaborator

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

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

Model Details: This study was a clustered, randomized, parallel, multicenter clinical trial.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: November 3, 2021
• Primary Completion: May 30, 2023
• Study Completion: December 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-01

Locations

TW (1)