Muscle WeaknessNCT03071354
Improving Muscle Function in Nutritionally at Risk, Elderly Patients
A study testing HMB protein supplement (3g) and Nutritional Supplement in people with Muscle Weakness and ICU-acquired Weakness, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The investigators propose to conduct a randomized, control trial of β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Muscle Weakness, ICU-acquired Weakness
- What is being tested?
- HMB protein supplement (3g) and Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 22 May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients age ≥65 years.
- Acute respiratory failure (ARF, defined by expected mechanical ventilation for > 72 hours from the point of screening)
- Elevated nutritional risk (NUTRIC score>5 - see below).
Who cannot join
- Over 72 hours from ICU admission.
- Not expected to survive another 48 hours
- Lack of commitment to full, aggressive care
- Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula),
- Pregnant women
- Prisoners
- Known allergy to study nutrients
- Unable to walk prior to current illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27105
About this study
Official title: Phase II, Multi-center, Randomized Control Trial of Beta- Hydroxy-Methyl-Butyrate (HMB) in Improving Physical Muscle Function, in Nutritionally at Risk, Elderly Patients
The investigators propose to conduct a randomized, control trial of β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).The investigators will measure functional outcomes using standard, validated measures prior and after discharge.
Read the detailed description
The investigators propose to conduct a randomized, control trial of HMB supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).the investigators will measure functional outcomes using standard, validated measures prior and after discharge.
The investigators hypothesize that this inexpensive nutrient, HMB, along with our supportive measures, reduces muscle loss, improves physical muscle function, and improves quality of life in the longer term following critical illness.
- Conditions
- Muscle Weakness, ICU-acquired Weakness
- Being tested
- HMB protein supplement (3g), Nutritional Supplement
- Keywords
- ICU-acquired weakness
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB protein supplement (3g)Dietary supplement
Also called Ensure Active™ Muscle Health
HMB 3g/day or iso-nitrogenous control (discussed below) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward. The dose of HMB was chosen based on multiple studies revealing efficacy of 3g/day improving muscle mass and demonstrating an excellent safety profile. Feeding will be initiated as per local practice. Enrolled patients will be randomized to supplementation with HMB (3g) or control will begin within 72 hours of admission to ICU.
Nutritional SupplementDietary supplement
Also called Ensure® Original
Control patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward throughout the study. While the patient is intubated, the control nutritional supplement will be delivered via the enteral feeding tube. The participant will switch to oral administration once extubated
| Study group | Role | What they receive |
|---|---|---|
| HMB Protein Supplementation Group | Experimental | Intervention patients will receive 2 x 237mL bottles of the commercially available liquid HMB protein supplement (3g) (Ensure Active™ Muscle Health) throughout the study.
In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards. Receives: Dietary Supplement: HMB protein supplement (3g) |
| Control Group | Active comparator | Control patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) throughout the study.
In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards. Receives: Dietary Supplement: Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk distance
Maximum distance walked by subject in 6 minutes on level ground
Measured: At 42 days follow up
Secondary outcomes (4)
Body Composition-Calf circumference
Measurement of the calf circumference
Measured: At 42 days follow up
Body Composition-Quadriceps layer muscle thickness (QLMT)
Thigh ultrasound for quadriceps muscle thickness
Measured: At 42 days follow up
Hand-grip strength (HGS)
Measurement of force of isometric grip strength using hand-held dynamometer
Measured: At 42 days follow up
Timed Get Up and Go test
Time for subject to go from sitting to standing unaided
Measured: At 42 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start1 May 2017
- Primary completion22 May 2017
- Study completion22 May 2017
Why it stopped: Principal Investigator is Moving Institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Agarwala, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071354
- Sponsor's protocol ID
- IRB00035962
- Status last verified
- Aug 2017
- First submitted
- 28 Feb 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multi-center, Randomized Control Trial of Beta- Hydroxy-Methyl-Butyrate (HMB) in Improving Physical Muscle Function, in Nutritionally at Risk, Elderly Patients
- ClinicalTrials.gov ID
- NCT03071354
- Acronym / sponsor ID
- IRB00035962
- Conditions
- Muscle Weakness, ICU-acquired Weakness
- Keywords
- ICU-acquired weakness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator is Moving Institutions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 6 Mar 2017 (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.
The investigators propose to conduct a randomized, control trial of β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).The investigators will measure functional outcomes using standard, validated measures prior and after discharge.
Detailed description
The investigators propose to conduct a randomized, control trial of HMB supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).the investigators will measure functional outcomes using standard, validated measures prior and after discharge.
The investigators hypothesize that this inexpensive nutrient, HMB, along with our supportive measures, reduces muscle loss, improves physical muscle function, and improves quality of life in the longer term following critical illness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB Protein Supplementation Group | Experimental | Dietary Supplement: HMB protein supplement (3g)Intervention patients will receive 2 x 237mL bottles of the commercially available liquid HMB protein supplement (3g) (Ensure Active™ Muscle Health) throughout the study. In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards. |
| Control Group | Active comparator | Dietary Supplement: Nutritional SupplementControl patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) throughout the study. In addition, all patients will be fed according to the Canadian Critical Nutrition Practice Guidelines, and protein/energy requirements will be determined by the local dietitians according to their local practice standards. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients age ≥65 years.
- Acute respiratory failure (ARF, defined by expected mechanical ventilation for > 72 hours from the point of screening)
- Elevated nutritional risk (NUTRIC score>5 - see below).
Key exclusion criteria (8 listed)
- Over 72 hours from ICU admission.
- Not expected to survive another 48 hours
- Lack of commitment to full, aggressive care
- Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula),
- Pregnant women
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 |
|---|---|---|
| HMB protein supplement (3g)Also: Ensure Active™ Muscle HealthHMB 3g/day or iso-nitrogenous control (discussed below) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward. The dose of HMB was chosen based on multiple studies revealing efficacy of 3g/day improving muscle mass and demonstrating an excellent safety profile. Feeding will be initiated as per local practice. Enrolled patients will be randomized to supplementation with HMB (3g) or control will begin within 72 hours of admission to ICU. | Dietary supplement | HMB Protein Supplementation Group |
| Nutritional SupplementAlso: Ensure® OriginalControl patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward throughout the study. While the patient is intubated, the control nutritional supplement will be delivered via the enteral feeding tube. The participant will switch to oral administration once extubated | Dietary supplement | Control Group |
Primary outcome
6 minute walk distance
Time frame: At 42 days follow up
Maximum distance walked by subject in 6 minutes on level ground
4 secondary outcomes
Body Composition-Calf circumference
Time frame: At 42 days follow up
Body Composition-Quadriceps layer muscle thickness (QLMT)
Time frame: At 42 days follow up
Hand-grip strength (HGS)
Time frame: At 42 days follow up
Timed Get Up and Go test
Time frame: At 42 days follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ravi Agarwala, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB protein supplement (3g) and Nutritional Supplement in people with Muscle Weakness and ICU-acquired Weakness, run by Wake Forest University Health Sciences at 1 site in United States.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 5 Feb 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
6 minute walk distance (time frame: At 42 days follow up). 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 5 Feb 2018.