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

NCT03792711 | Completed

• 1 other identifier: ANTW1701
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• lean body mass

  Thigh muscle mass (kg) will be measured by MRI and be further analyzed at Visits 1 and 3 (EOS/ET). The data assessed at Visit 1 will be the baseline. The summary results of thigh muscle mass (kg) at the baseline and subsequent visits, and the change from baseline will be summarized descriptively by groups. Changes from baseline within each group will be tested by paired t-test or Wilcoxon signed-rank test with a significance level of 0.05. The change from baseline between groups will be analyzed by two sample t-test or Wilcoxon rank-sum test.

  3 months

Study Arms (2)

HMB group

EXPERIMENTAL

2 servings (440 mL)/day Ensure® Plus Advance for use as a supplement with or between meals

Dietary Supplement: Ensure® Plus Advance

Control group

NO INTERVENTION

Standard of care includes mainly dietary consultation for healthy aging by dietitians to reach sufficient dietary protein intake.

Interventions

Ensure® Plus Advance DIETARY_SUPPLEMENT

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.

HMB group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female subject with age between 65-80 years old (inclusive)
• Subject with pre-frail status, which is defined by Fried's criteria
• Subject who can fully communicate, understand the study, and provide the informed consent

You may not qualify if:

• Subject with BMI \> 35 kg/m2
• Subject with active diseases judged by the investigator as below
• Recent stroke (within 6 months prior to screening)
• Parkinsonism
• Motor neuron disease
• Uncontrolled cardiovascular disease
• Uncontrolled chronic obstructive pulmonary disease
• Chronic kidney disease severe than Stage IIIb
• Dementia or other mental illness with cognitive impairment
• Uncontrolled depression
• Chronic and acute infection
• Uncontrolled metabolic diseases including type II diabetes mellitus
• Thyroid disease, including hypothyroidism and hyperthyroidism
• Uncontrolled gastrointestinal disease (inflammatory bowel disease, Crohn's disease, etc)
• Subject with a history or evidence of malignancy in the past 5 years (except for non-melanoma skin neoplasia)

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

Taiwan Association of Integrated Care

Taipei, Taiwan

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Study Officials

• Liang-Kung Chen, PhD

  Institute of Health Policy and Welfare, National Yang-Ming University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: January 3, 2019
• Study Start: February 18, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 11, 2022

Record last verified: 2019-07

Locations

TW (1)