Frail Elderly SyndromeNCT03792711
The Effects of the Oral Nutritional Supplement With β-hydroxy-β-methylbutyrate in Lean Body Mass Among Taiwan Elderly
A study testing Ensure® Plus Advance in people with Frail Elderly Syndrome and Nutrition Disorders in Old Age, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome, Nutrition Disorders in Old Age, Muscle Loss
- What is being tested?
- Ensure® Plus Advance
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Feb 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled, Open-label, Parallel-group, Randomized Study to Evaluate the Effects of Additional Oral Nutritional Supplement With β-hydroxy-β-methylbutyrate on Thigh Muscle Mass in Older People With Pre-frail Status in Taiwan
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:
- 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
- To determine the safety profile of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate in elderly subjects with pre-frail status
Read the 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® Plus Advance) on thigh muscle mass and physical performance in elderly subjects with pre-frail status. The study is planned to enroll a total of 70 elderly subjects with pre-frail status defined by Fried's criteria with modified cutoff values as suggested by Asian Working Group for Sarcopenia (AWGS) for Asian population. The subject to be enrolled will meet the phenotypic definition of pre-frail for one or two of five phenotypic criteria: weakness as measured by grip strength, slow walking speed, low level of physical activity, self-reported exhaustion, and unintentional weight loss.
After obtaining informed consent and the confirmation of eligibility, subjects will be randomized into the HMB or control group in a 1:1 ratio. All enrolled subjects will be under standard care, which is mainly dietary consultation for healthy aging by dietitians to assure sufficient dietary protein intake in all subjects. Subjects assigned to the HMB group will consume 2 bottles of Ensure® Plus Advance per day for 12 weeks additionally, while subjects assigned to the control group will not receive any placebo or active control.
In this study, subjects will be requested for a total of 4 visits at the clinical site, including screening visit, Visit 1 for randomization, Visit 2 at Week 6, and Visit 3 at Week 12 (end of study/EOS). The telephone visit will be scheduled at Week 3 and Week 9 to follow-up with subjects.
Thigh muscle mass of all subjects will be evaluated by MRI. The physical performance of subjects will be determined by short physical performance battery (SPPB) and handgrip strength. The nutrition status of subjects will be measured by MNA® -SF and nutrition biomarkers, including serum albumin, pre-albumin, 25-hydroxy-vitamin D, vitamin B12, and C-reactive protein (CRP). SF-36v2™ Health Survey will be used to evaluate the quality of life of subjects. The safety profile of Ensure® Plus Advance will be determined by monitoring the adverse event (AE/SAE) during the study period. Blood samples of each subject will be collected at Visits 1, 2 and 3 for analysis of nutrition biomarkers. There will be a total of approximately 30 mL of blood to be collected from each subject during the study period.
- Being tested
- Ensure® Plus Advance
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure® Plus AdvanceDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| HMB group | Experimental | 2 servings (440 mL)/day Ensure® Plus Advance for use as a supplement with or between meals Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start18 Feb 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang-Kung Chen, PhD, Principal investigator, Institute of Health Policy and Welfare, National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792711
- Sponsor's protocol ID
- ANTW1701
- Status last verified
- Jul 2019
- First submitted
- 11 Dec 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Open-label, Parallel-group, Randomized Study to Evaluate the Effects of Additional Oral Nutritional Supplement With β-hydroxy-β-methylbutyrate on Thigh Muscle Mass in Older People With Pre-frail Status in Taiwan
- ClinicalTrials.gov ID
- NCT03792711
- Acronym / sponsor ID
- ANTW1701
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- To determine the safety profile of additional oral nutritional supplement containing β-hydroxy-β-methylbutyrate in elderly subjects with pre-frail status
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® Plus Advance) on thigh muscle mass and physical performance in elderly subjects with pre-frail status. The study is planned to enroll a total of 70 elderly subjects with pre-frail status defined by Fried's criteria with modified cutoff values as suggested by Asian Working Group for Sarcopenia (AWGS) for Asian population. The subject to be enrolled will meet the phenotypic definition of pre-frail for one or two of five phenotypic criteria: weakness as measured by grip strength, slow walking speed, low level of physical activity, self-reported exhaustion, and unintentional weight loss.
After obtaining informed consent and the confirmation of eligibility, subjects will be randomized into the HMB or control group in a 1:1 ratio. All enrolled subjects will be under standard care, which is mainly dietary consultation for healthy aging by dietitians to assure sufficient dietary protein intake in all subjects. Subjects assigned to the HMB group will consume 2 bottles of Ensure® Plus Advance per day for 12 weeks additionally, while subjects assigned to the control group will not receive any placebo or active control.
In this study, subjects will be requested for a total of 4 visits at the clinical site, including screening visit, Visit 1 for randomization, Visit 2 at Week 6, and Visit 3 at Week 12 (end of study/EOS). The telephone visit will be scheduled at Week 3 and Week 9 to follow-up with subjects.
Thigh muscle mass of all subjects will be evaluated by MRI. The physical performance of subjects will be determined by short physical performance battery (SPPB) and handgrip strength. The nutrition status of subjects will be measured by MNA® -SF and nutrition biomarkers, including serum albumin, pre-albumin, 25-hydroxy-vitamin D, vitamin B12, and C-reactive protein (CRP). SF-36v2™ Health Survey will be used to evaluate the quality of life of subjects. The safety profile of Ensure® Plus Advance will be determined by monitoring the adverse event (AE/SAE) during the study period. Blood samples of each subject will be collected at Visits 1, 2 and 3 for analysis of nutrition biomarkers. There will be a total of approximately 30 mL of blood to be collected from each subject during the study period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB group | Experimental | Dietary Supplement: Ensure® Plus Advance2 servings (440 mL)/day Ensure® Plus Advance for use as a supplement with or between meals |
| Control group | No intervention | –Standard of care includes mainly dietary consultation for healthy aging by dietitians to reach sufficient dietary protein intake. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure® Plus AdvancePrevious 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. | Dietary supplement | HMB group |
Primary outcome
lean body mass
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
Related trials for Frail Elderly Syndrome
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome
Recruiting
Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
Frailty Syndrome, Older Adults
Recruiting
Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-Kung Chen, PhD principal investigator
Institute of Health Policy and Welfare, National Yang-Ming University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure® Plus Advance in people with Frail Elderly Syndrome and Nutrition Disorders in Old Age, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lean body mass (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.