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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04079010
Enrollment
30
Registered
2019-09-06
Start date
2019-09-04
Completion date
2019-11-25
Last updated
2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Flow Restriction, Growth Hormone, Strength Outcomes, Arginine

Keywords

blood flow restriction, growth hormone, strength outcomes, arginine

Brief 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).

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.

Interventions

PROCEDUREBFR

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_SUPPLEMENTArginine

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.

DIETARY_SUPPLEMENTPlacebo 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.

Sponsors

University of Mary Hardin-Baylor
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
StrengthBaseline 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 baseline1 RM (rep-max) will be utilized to measure lower extremity strength

Secondary

MeasureTime frameDescription
Growth FactorMeasured 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

MeasureTime frameDescription
CortisolMeasured 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026