Strength Testing After Nitrate Delivery (STAND) in ICU Patients
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|ClinicalTrials.gov Identifier: NCT02293616|
Recruitment Status : Completed
First Posted : November 18, 2014
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure||Dietary Supplement: Nitrate Rich Beetroot Juice Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Strength Testing After Nitrate Delivery (STAND) in ICU Patients|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
Experimental: Nitrate Rich
A nitrate rich beetroot juice supplement (Beet It Shot®, James White Drinks, UK) high in nitrates will be provided to the subjects. Subject's diet will be supplemented once daily while hospitalized up to 14 days with one 70 ml bottle containing 300 mg of dietary nitrate.
Dietary Supplement: Nitrate Rich Beetroot Juice
Nitrate rich beetroot juice diet supplement will be consumed by subjects.
Other Name: Beet It Shot®
Placebo Comparator: Nitrate Depleted
This group will consume a beetroot juice supplement (Beet It Shot®, James White Drinks, UK) that has had the nitrate removed from the beverage by the manufacturer. Patient's diet will be supplemented once daily with one 70 ml bottle while hospitalized up to 14 days.
Dietary Supplement: Placebo
- physical function assessed using the Short Physical Performance Battery (SPPB) [ Time Frame: 2 months ]The SPPB is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each performance measure is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 inability to complete the test. A summary score (range 0-12) will be calculated by adding the three scores.
- Plasma Nitrate and Nitrite Levels [ Time Frame: 5 days ]Blood samples will be collected in 4 mL lithium heparin vials. Nitrate and nitrite will be measured separately using the ENO-20 NOx analyzer.
- Skeletal muscle strength [ Time Frame: 2 months ]Skeletal muscle strength will be measured in both upper and lower extremities. Hand grip strength in both hands will be measured using a hand held grip strength dynamometer. Additionally, an electronic strength dynamometer will be used to collect strength measures of the elbow flexion, elbow extension, shoulder flexion in the scaption plane, ankle dorsiflexion, knee extension and hip extension, bilaterally. Skeletal muscle ultrasound will be performed on upper and lower extremities bilaterally.
- Hospital Length of Stay [ Time Frame: 2 weeks ]The hospital calendar days (or any portion of a calendar day) at the enrolling hospital and at any long term acute care facility to which the subject is directly transferred.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293616
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||D. Clark Files, MD||Wake Forest University Health Sciences|