Blood Flow RestrictionNCT04079010
The Effect of Blood Flow Restriction With and Without Arginine on Physical Performance and Growth Hormone
A study testing BFR and Arginine in people with Blood Flow Restriction and Growth Hormone, run by University of Mary Hardin-Baylor at 1 site in United States.
Trial summary
The current study will investigate the effects of Blood Flow Restriction (BFR) training and L-arginine supplementation on recreationally trained female participants. In particular, it will compare performance outcomes and blood markers among two intervention groups (BFR and BFR+Arg) and a control group (CON). Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction, Growth Hormone, Strength Outcomes
- What is being tested?
- BFR and Arginine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 25 Nov 2019
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- PAR-Q form complete and without contraindications
- Body Mass Index (BMI) of 18.5-29.9 kg/m2
- Stable body weight prior to participation in the study (fluctuation not exceeding 10 lbs. within the past 6 months
- Agreement not to change current diet or exercise program (other than adding the program for the purpose of this study)
Who cannot join
- Any diagnosed orthopedic condition that prevents exercise
- BMI > 29.9 kg/m2 or < 18.5 kg/m2
- Affirmative answer to any of the questions presented on the PAR-Q form
- Are currently pregnant or planning to become pregnant during the study
- Currently taking blood pressure medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mary Hardin-Baylor
Belton, Texas, 76513
About this study
The current study will investigate the effects of Blood Flow Restriction (BFR) training and L-arginine supplementation on recreationally trained female participants. In particular, it will compare performance outcomes and blood markers among two intervention groups (BFR and BFR+Arg) and a control group (CON).
Read the detailed description
The current study will investigate the effects of Blood Flow Restriction (BFR) training and L-arginine supplementation on recreationally trained female participants. In particular, it will compare performance outcomes and blood markers among two intervention groups (BFR and BFR+Arg) and a control group (CON). All group will participate in the same training regimen. The control group will train and ingest a placebo pill. The BFR group will train with BFR and ingest a placebo pill, and the BFR+Arg group will train with BFR and ingest an L-arginine pill. All placebo pills will be Maltodextrin. The performance outcome is leg press 1RM, while the blood markers are growth hormone (GH) and cortisol. This analysis will provide insight as to whether or not L-arginine supplementation in addition to blood flow restriction training improves performance and muscle hypertrophy measure more than blood flow restriction training alone.
- Conditions
- Blood Flow Restriction, Growth Hormone, Strength Outcomes, Arginine
- Being tested
- BFR, Arginine, Placebo Pill
- Keywords
- blood flow restriction, growth hormone, strength outcomes, arginine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRProcedure or surgery
Blood flow restriction (BFR) training is a non-invasive technique that uses wraps, bands, or inflated blood pressure cuffs to change blood flow within targeted muscles. Occlusion pressure of the femoral artery will be determine before each training session using the Delfi Personalize Tourniquet System for Blood Flow Restriction (2.0) which has embedded ultrasound technology to continually measure the blood flow and with auto-adjust the pressure. The target percent of occlusion is 50% of total blood flow while completed a prescribed resistance training regimen 4 times per week.
ArginineDietary supplement
The BFR+Arg group will consume Arginine supplement daily throughout the course of the study. Supplements were manufactured by Kyowa, a US-based cGMP-compliant contract manufacturing facility independently audited and pre-qualified by the quality compliance firm, Obvium*Q, LLC (Dallas, TX). Manufacturing batch records for production of each of the supplements were maintained by the manufacturer and finished supplements were independently assayed for identity, purity, potency, and composition using appropriate USP, AOAC, or BAM methods at the independent, analytical laboratory, Dyad Labs (Salt Lake City, UT), prior to approval for release and consumption of the supplements by participants.
Each serving of the supplements were formulated to contain 3,000 mg L-Arginine (ARG; Kyowa). Each supplement also contained the inert and non-insulinotropic excipient ingredients, microcystalline cellulose and silicon dioxide.
Placebo PillDietary supplement
Also called Maltodextrose
The CON and BFR groups will consume placebo pill daily throughout the course of the study. Supplements were manufactured by Kyowa, a US-based cGMP-compliant contract manufacturing facility independently audited and pre-qualified by the quality compliance firm, Obvium*Q, LLC (Dallas, TX). Manufacturing batch records for production of each of the supplements were maintained by the manufacturer and finished supplements were independently assayed for identity, purity, potency, and composition using appropriate USP, AOAC, or BAM methods at the independent, analytical laboratory, Dyad Labs (Salt Lake City, UT), prior to approval for release and consumption of the supplements by participants.
Each serving of the supplements were formulated to contain 3,000 mg Maltodextrin placebo (PLA; MALTRIN-M100; Grain Processing Corporation; Muscantine, IA). Each supplement also contained the inert and non-insulinotropic excipient ingredients, microcystalline cellulose and silicon dioxide.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants will adhere to resistance training protocol. Receives: Dietary Supplement: Placebo Pill |
| BFR (blood flow restriction) | Active comparator | Participants will adhere to resistance training protocol, while also applying a blood flow restriction cuff during resistance training. Receives: Procedure: BFR; Dietary Supplement: Placebo Pill |
| BFR (blood flow restriction), plus Arginine | Active comparator | Participants will adhere to resistance training protocol, apply a blood flow restriction cuff during resistance training, and will take the clinically safe dose of arginine prior to training sessions. Receives: Procedure: BFR; Dietary Supplement: Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
1 RM (rep-max) will be utilized to measure lower extremity strength
Measured: Baseline measurements will be obtained during Week 0, then measurements will be taken at Week 4 and Week 8 to determine the amount of change in participant's strength at those particular time points compared to baseline
Secondary outcomes (1)
Growth Factor
Growth Hormone will be assessed by blood draw in an acute response design
Measured: Measured at Week 0, Week 4, and Week 8 at the following intervals: prior to supplement, 15 and 30 minutes post-supplementation (before exercise), and 90 minutes post-supplementation (after exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start4 Sep 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow RestrictionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mary Hardin-Baylor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristi Trammell, University of Mary Hardin-Baylor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079010
- Sponsor's protocol ID
- 57
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2019
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Flow Restriction With and Without Arginine on Physical Performance and Growth Hormone
- ClinicalTrials.gov ID
- NCT04079010
- Acronym / sponsor ID
- 57
- Conditions
- Blood Flow Restriction, Growth Hormone, Strength Outcomes, Arginine
- Keywords
- blood flow restriction, growth hormone, strength outcomes, arginine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Mary Hardin-BaylorUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 6 Sep 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.
The current study will investigate the effects of Blood Flow Restriction (BFR) training and L-arginine supplementation on recreationally trained female participants. In particular, it will compare performance outcomes and blood markers among two intervention groups (BFR and BFR+Arg) and a control group (CON).
Detailed description
The current study will investigate the effects of Blood Flow Restriction (BFR) training and L-arginine supplementation on recreationally trained female participants. In particular, it will compare performance outcomes and blood markers among two intervention groups (BFR and BFR+Arg) and a control group (CON). All group will participate in the same training regimen. The control group will train and ingest a placebo pill. The BFR group will train with BFR and ingest a placebo pill, and the BFR+Arg group will train with BFR and ingest an L-arginine pill. All placebo pills will be Maltodextrin. The performance outcome is leg press 1RM, while the blood markers are growth hormone (GH) and cortisol. This analysis will provide insight as to whether or not L-arginine supplementation in addition to blood flow restriction training improves performance and muscle hypertrophy measure more than blood flow restriction training alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Placebo PillParticipants will adhere to resistance training protocol. |
| BFR (blood flow restriction) | Active comparator | Procedure: BFR, Dietary Supplement: Placebo PillParticipants will adhere to resistance training protocol, while also applying a blood flow restriction cuff during resistance training. |
| BFR (blood flow restriction), plus Arginine | Active comparator | Procedure: BFR, Dietary Supplement: ArginineParticipants will adhere to resistance training protocol, apply a blood flow restriction cuff during resistance training, and will take the clinically safe dose of arginine prior to training sessions. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent
- PAR-Q form complete and without contraindications
- Body Mass Index (BMI) of 18.5-29.9 kg/m2
- Stable body weight prior to participation in the study (fluctuation not exceeding 10 lbs. within the past 6 months
- Agreement not to change current diet or exercise program (other than adding the program for the purpose of this study)
Key exclusion criteria (5 listed)
- Any diagnosed orthopedic condition that prevents exercise
- BMI > 29.9 kg/m2 or < 18.5 kg/m2
- Affirmative answer to any of the questions presented on the PAR-Q form
- Are currently pregnant or planning to become pregnant during the study
- Currently taking blood pressure medication
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 |
|---|---|---|
| BFRBlood flow restriction (BFR) training is a non-invasive technique that uses wraps, bands, or inflated blood pressure cuffs to change blood flow within targeted muscles. Occlusion pressure of the femoral artery will be determine before each training session using the Delfi Personalize Tourniquet System for Blood Flow Restriction (2.0) which has embedded ultrasound technology to continually measure the blood flow and with auto-adjust the pressure. The target percent of occlusion is 50% of total blood flow while completed a prescribed resistance training regimen 4 times per week. | Procedure or surgery | BFR (blood flow restriction), BFR (blood flow restriction), plus Arginine |
| ArginineThe BFR+Arg group will consume Arginine supplement daily throughout the course of the study. Supplements were manufactured by Kyowa, a US-based cGMP-compliant contract manufacturing facility independently audited and pre-qualified by the quality compliance firm, Obvium*Q, LLC (Dallas, TX). Manufacturing batch records for production of each of the supplements were maintained by the manufacturer and finished supplements were independently assayed for identity, purity, potency, and composition using appropriate USP, AOAC, or BAM methods at the independent, analytical laboratory, Dyad Labs (Salt Lake City, UT), prior to approval for release and consumption of the supplements by participants. Each serving of the supplements were formulated to contain 3,000 mg L-Arginine (ARG; Kyowa). Each supplement also contained the inert and non-insulinotropic excipient ingredients, microcystalline cellulose and silicon dioxide. | Dietary supplement | BFR (blood flow restriction), plus Arginine |
| Placebo PillAlso: MaltodextroseThe CON and BFR groups will consume placebo pill daily throughout the course of the study. Supplements were manufactured by Kyowa, a US-based cGMP-compliant contract manufacturing facility independently audited and pre-qualified by the quality compliance firm, Obvium*Q, LLC (Dallas, TX). Manufacturing batch records for production of each of the supplements were maintained by the manufacturer and finished supplements were independently assayed for identity, purity, potency, and composition using appropriate USP, AOAC, or BAM methods at the independent, analytical laboratory, Dyad Labs (Salt Lake City, UT), prior to approval for release and consumption of the supplements by participants. Each serving of the supplements were formulated to contain 3,000 mg Maltodextrin placebo (PLA; MALTRIN-M100; Grain Processing Corporation; Muscantine, IA). Each supplement also contained the inert and non-insulinotropic excipient ingredients, microcystalline cellulose and silicon dioxide. | Dietary supplement | BFR (blood flow restriction), Control |
Primary outcome
Strength
Time frame: Baseline measurements will be obtained during Week 0, then measurements will be taken at Week 4 and Week 8 to determine the amount of change in participant's strength at those particular time points compared to baseline
1 RM (rep-max) will be utilized to measure lower extremity strength
1 secondary outcome
Growth Factor
Time frame: Measured at Week 0, Week 4, and Week 8 at the following intervals: prior to supplement, 15 and 30 minutes post-supplementation (before exercise), and 90 minutes post-supplementation (after exercise)
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 2 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR and Arginine in people with Blood Flow Restriction and Growth Hormone, run by University of Mary Hardin-Baylor 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 5 inclusion and 5 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 2 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Strength (time frame: Baseline measurements will be obtained during Week 0, then measurements will be taken at Week 4 and Week 8 to determine the amount of change in participant's strength at those particular time points compared to baseline). 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 2 Apr 2020.