The Effect of Blood Flow Restriction With and Without Arginine on Physical Performance and Growth Hormone

Blood Flow Restriction Clinical Trial

Official title:

The Effect of Blood Flow Restriction With and Without Arginine on Physical Performance and Growth Hormone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079010
• Other study ID #: 57
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: March 2020
• Source: University of Mary Hardin-Baylor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arginine
• Blood Flow Restriction
• Growth Hormone
• Strength Outcomes

Intervention

Procedure:
• BFR
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.

Dietary Supplement:
• Arginine
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 Pill
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.

Locations

Country	Name	City	State
United States	University of Mary Hardin-Baylor	Belton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Mary Hardin-Baylor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol	Cortisol will be assessed by blood draw in an acute response design	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)
Primary	Strength	1 RM (rep-max) will be utilized to measure lower extremity strength	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	Growth Factor	Growth Hormone will be assessed by blood draw in an acute response design	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)