Impact of Citrulline and Arginine Supplementation on the Post-exercise Hypotension (PEH)

NCT03378596 | Unknown

• 1 other identifier: 2016-0108
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Post-exercise hypotension (PEH) is a established phenomenon as one of the non-pharmacological ways of reducing blood pressure, producing important impacts, particularly in hypertensive individuals. However, the factors involved in the magnitude and duration of this effect are relatively little studied. Thus, the bioavailability of vasodilatation mediators may maximize the duration and magnitude of PEH. In this sense, the objective of the present project will be to verify the impact of L-citrulline associated with L-arginine supplementation on the acute blood pressure response after an aerobic exercise session. Approximately 80 adults (40 normotensive and 40 hypertensive) will be selected. The sample will be submitted to measurements of body mass, height and resting blood pressure. After the minimum interval of 48 h, subjects will be randomly submitted to four experimental situations (exercise/L-citrulline, exercise/L-arginine, exercise/placebo, exercise/L-citrulline + L-arginine). The exercise sessions (40 min in treadmill at 60% of FCres) will be performed with a minimum interval of 48 h. After each session, the blood pressure of the sample will be recorded during 24 hours. For data analysis, blood pressure values will be plotted in average of the wakefulness and average of the sleep periods and average of the 24 hours. The comparisons will be made through the ANOVA (repeated measures), following the recommended assumptions. It is hoped that the results of this project will collaborate to the knowledge regarding non-pharmacological models aimed at the prevention and treatment of hypertension in normotensive and hypertensive patients.

Conditions

Hypertension

Keywords

Post-Exercise Hypotension; Exercise; Arginine; Citrulline

Outcome Measures

Primary Outcomes (1)

• Ambulatorial Blood Pressure Monitoring

  The ambulatorial blood pressure measurements will be taken with oscillometric device (Dyna-MAPA - São Paulo, Brazil) attached on the left arm. The participants will received instructions to keep the arm stand during the measures. The monitor will be setting to register the systolic and diastolic blood pressure and heart rate every 20 minutes during "daytime" (08:00am to 11:00pm) and every 30 minutes during "night-time" (11:00pm to 08:00am) to reduce sleep disturbs. The device screen will be electronically blinded to avoid feedback. The metric measures will be reported by millimeters of mercury (mmHg).

  24 hours

Study Arms (4)

L-citrulline & L-arginine

EXPERIMENTAL

L-citrulline (6 grams) L-arginine (8 grams)

Dietary Supplement: L-citrulline + L-arginine

L-citrulline & Placebo

ACTIVE COMPARATOR

L-citrulline (6 grams) Placebo (6 grams)

Dietary Supplement: L-citrulline; Dietary Supplement: Placebo

L-arginine & Placebo

ACTIVE COMPARATOR

L-arginine (8 grams) Placebo (6 grams)

Dietary Supplement: L-arginine; Dietary Supplement: Placebo

Placebo

ACTIVE COMPARATOR

Placebo (6 grams)

Dietary Supplement: Placebo

Interventions

L-citrulline + L-arginine DIETARY_SUPPLEMENT

L-citrulline + L-arginine - sachet dissolved in water

L-citrulline & L-arginine

L-arginine DIETARY_SUPPLEMENT

L-arginine - sachet dissolved in water

L-arginine & Placebo

L-citrulline DIETARY_SUPPLEMENT

L-citrulline - sachet dissolved in water

L-citrulline & Placebo

Placebo DIETARY_SUPPLEMENT

Placebo (corn starch) - sachet dissolved in water

L-arginine & Placebo; L-citrulline & Placebo; Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertensive and Normotensive, without osteoarticular disabilities and medical authorization to physical exercise practice.

Sponsors & Collaborators

• Juliano Casonatto: lead

Study Sites (1)

Juliano Casonatto

Londrina, Paraná, 86025-170, Brazil

RECRUITING

Related Publications (8)

• Borg G. Borg's Perceived Exertion and Pain Scales. Champaign: Human Kinetics; 1998.

  BACKGROUND

• Gordon CC, Chumlea WC, Roche AF. Stature, recumbent length, and weight. Lohman TG, Roche AF, Martorell R, editors. Champaign: Human Kinetics Books; 1988. 3-8 p.

  BACKGROUND

• Coleman A, Freeman P, Steel S, Shennan A. Validation of the Omron MX3 Plus oscillometric blood pressure monitoring device according to the European Society of Hypertension international protocol. Blood Press Monit. 2005 Jun;10(3):165-8. doi: 10.1097/00126097-200506000-00009.

  PMID: 15923819 BACKGROUND

• Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ; Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Recommendations for blood pressure measurement in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension. 2005 Jan;45(1):142-61. doi: 10.1161/01.HYP.0000150859.47929.8e. Epub 2004 Dec 20.

  PMID: 15611362 BACKGROUND

• Quintana DS, Heathers JA, Kemp AH. On the validity of using the Polar RS800 heart rate monitor for heart rate variability research. Eur J Appl Physiol. 2012 Dec;112(12):4179-80. doi: 10.1007/s00421-012-2453-2. Epub 2012 Jul 13. No abstract available.

  PMID: 22790488 BACKGROUND

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Casonatto J, Tinucci T, Dourado AC, Polito M. Cardiovascular and autonomic responses after exercise sessions with different intensities and durations. Clinics (Sao Paulo). 2011;66(3):453-8. doi: 10.1590/s1807-59322011000300016.

  PMID: 21552672 BACKGROUND

• Domingues V, Cavalari JV, Grandolfi K, Aguiar AF, Borghi SM, Casonatto J. Acute Effects of Citrulline Malate Supplementation on Nocturnal Blood Pressure Dipping After Exercise in Hypertensive Patients: A Randomized, Placebo-Controlled Trial. J Diet Suppl. 2024;21(6):868-880. doi: 10.1080/19390211.2024.2414052. Epub 2024 Oct 10.

  PMID: 39385595 DERIVED

MeSH Terms

Conditions

Hypertension; Post-Exercise Hypotension; Motor Activity

Interventions

Citrulline; Arginine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Juliano Casonatto, PhD

CONTACT

55-43-999840790; juliano2608@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Clinical Research

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: January 2, 2018
• Primary Completion: January 31, 2018
• Study Completion: February 28, 2018
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

BR (1)