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The Effects of the Oral Nutritional Supplement With β-hydroxy-β-methylbutyrate in Lean Body Mass Among Taiwan Elderly

NCT03792711 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-04-11

No results posted yet for this study

Summary

Primary objective:

To evaluate the effects of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate (HMB) on thigh muscle mass in elderly subjects with pre-frail status

Secondary objectives:

1. To evaluate the effects of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate on physical performance, nutrition status, and quality of life in elderly subjects with pre-frail status
2. To determine the safety profile of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate in elderly subjects with pre-frail status

Conditions

  • Frail Elderly Syndrome
  • Nutrition Disorders in Old Age
  • Muscle Loss

Interventions

DIETARY_SUPPLEMENT

Ensure® Plus Advance

Previous studies suggest that protein supplementation is an effective dietary strategy to decrease frailty by positively influence the weight loss or sarcopenia in elderly. Lean body mass includes all body tissue except fat and is well recognized to be associated with an increased risk of morbidity and mortality. Oral nutrition supplements have been shown to increase food intake and body weight, but not lean body mass. In previous studies, β-hydroxy-β-methylbutyrate, which is leucine metabolite, has been shown to enhance protein synthesis and decrease protein degradation leading to increase lean body mass. It showed that β-hydroxy-β-methylbutyrate supplement with exercise increased lean body mass in health elderly population and improved the physical performance in elderly women.

Sponsors & Collaborators

  • National Yang Ming Chiao Tung University

    lead OTHER

Principal Investigators

  • Liang-Kung Chen, PhD · Institute of Health Policy and Welfare, National Yang-Ming University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792711 on ClinicalTrials.gov