Status:
COMPLETED
The Effects of the Oral Nutritional Supplement With β-hydroxy-β-methylbutyrate in Lean Body Mass Among Taiwan Elderly
Lead Sponsor:
National Yang Ming Chiao Tung University
Conditions:
Frail Elderly Syndrome
Nutrition Disorders in Old Age
Eligibility:
All Genders
65-80 years
Phase:
NA
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 Second...
Detailed Description
This is a controlled, open-label, parallel-group, randomized, investigator initiated study to evaluate the effectiveness of oral nutritional supplement containing β-hydroxy-β-methylbutyrate (Ensure® P...
Eligibility Criteria
Inclusion
- Subjects have to meet ALL inclusion criteria to be eligible for participation in the study.
- 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
Exclusion
- Subjects who meet ANY of the following exclusion criteria will be excluded from the study.
- 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)
- Subject using any dietary supplementation containing β-hydroxy-β-methylbutyrate within 1 month prior to screening
- Subject using Ensure® plus Advance within 1 month prior to screening
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03792711
Start Date
February 18 2019
End Date
December 30 2020
Last Update
April 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Taiwan Association of Integrated Care
Taipei, Taiwan