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Completed

NCT Number: NCT04079010

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

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).

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Mary Hardin-Baylor

Belton, Texas, 76513, United States

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). 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BFR

Procedure

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.

Arginine

Dietary 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 Pill

Dietary Supplement

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.

Other names: Maltodextrose

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    Growth Hormone will be assessed by blood draw in an acute response design

Other outcomes

  1. Cortisol

    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)

    Cortisol will be assessed by blood draw in an acute response design

Sponsors and collaborators

Lead sponsor

University of Mary Hardin-Baylor

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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