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

NCT04079010 | Completed

• 1 other identifier: 57
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Flow Restriction; Growth Hormone; Strength Outcomes; Arginine

Keywords

blood flow restriction; growth hormone; strength outcomes; arginine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Growth Factor

  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)

Other Outcomes (1)

• Cortisol

  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)

Study Arms (3)

Control

PLACEBO COMPARATOR

Participants will adhere to resistance training protocol.

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.

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.

Procedure: BFR; Dietary Supplement: Arginine

Interventions

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.

BFR (blood flow restriction); BFR (blood flow restriction), plus Arginine

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.

BFR (blood flow restriction), plus Arginine

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.

Also known as: Maltodextrose

BFR (blood flow restriction); Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mary Hardin-Baylor: lead

Study Sites (1)

University of Mary Hardin-Baylor

Belton, Texas, 76513, United States

Location

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Doctor of Physical Therapy program

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: September 4, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)