Effects of L-arginine and L-citrulline Supplementation on Muscle Respiration

NCT03998800 | Completed

• 1 other identifier: R19-P010
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to determine the effects of dietary supplementation with the amino acids, L-arginine and L-citrulline, on endurance performance and mitochondrial respiration in healthy men compared to supplementation with L-arginine alone and a placebo supplement.

Conditions

Dietary Exposure

Keywords

Endurance performance; Mitochondrial function; L-arginine; L-citrulline; Healthy males

Outcome Measures

Primary Outcomes (4)

• Change in Endurance performance on a cycle ergometer between L-arginine supplementation and placebo supplementation

  On day 10 of the supplementation periods, subjects will complete a performance test on a cycle ergometer to investigate their endurance performance

  8-11 weeks

• Change in Endurance performance on a cycle ergometer between L-arginine + L-citrulline supplementation and placebo supplementation

  On day 10 of the supplementation periods, subjects will complete a performance test on a cycle ergometer to investigate their endurance performance

  8-11 weeks

• Changes of mitochondrial function in skeletal muscle between L-arginine supplementation and placebo supplementation

  On day 7 of the supplementation periods, a skeletal muscle biopsy sample will be obtained from subjects to investigate mitochondrial function.

  8-11 weeks

• Changes of mitochondrial function in skeletal muscle between L-arginine + L-citrulline supplementation and placebo supplementation

  On day 7 of the supplementation periods, a skeletal muscle biopsy sample will be obtained from subjects to investigate mitochondrial function.

  8-11 weeks

Secondary Outcomes (6)

• Changes of amino acid and nitric oxide biomarkers levels in plasma between L-arginine supplementation and placebo supplementation

  8-11 weeks

• Changes of amino acid and nitric oxide biomarkers levels in plasma between L-arginine + L-citrulline supplementation and placebo supplementation

  8-11 weeks

• Changes in muscle oxygenation between L-arginine supplementation and placebo supplementation

  8-11 weeks

• Changes in muscle oxygenation between L-arginine + L-citrulline supplementation and placebo supplementation

  8-11 weeks

• Changes in subjective feeling during and after exercise between L-arginine supplementation and placebo supplementation

  8-11 weeks

Study Arms (3)

L-arginine and L-citrulline

EXPERIMENTAL

10 days of supplementation with 1.5 g of L-arginine and 1.5 g of L-citrulline per day

Dietary Supplement: Dietary Supplement; Behavioral: Endurance exercise on a cycle ergometer

L-arginine

EXPERIMENTAL

10 days of supplementation with 3 g of L-arginine per day

Dietary Supplement: Dietary Supplement; Behavioral: Endurance exercise on a cycle ergometer

Placebo (corn-starch)

PLACEBO COMPARATOR

10 days of supplementation with corn-starch

Dietary Supplement: Dietary Supplement; Behavioral: Endurance exercise on a cycle ergometer

Interventions

Dietary Supplement DIETARY_SUPPLEMENT

Dietary Supplement: L-arginine and L-citrulline supplement, L-arginine supplement, or placebo supplement (corn-starch) Subjects will complete 3 individual 10 day supplementation periods, separated by washout periods of approximately 2 weeks.

L-arginine; L-arginine and L-citrulline; Placebo (corn-starch)

Endurance exercise on a cycle ergometer BEHAVIORAL

On day 10 of each supplementation period, subjects will complete a performance test on a cycle ergometer to investigate their endurance performance.

L-arginine; L-arginine and L-citrulline; Placebo (corn-starch)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male, 18-40 years of age
• recreationally-active
• healthy BMI (≥18.5 and ≤24.9 kg/m2)

You may not qualify if:

• participating in other studies currently or in the past two months or has an intention to participate in other studies over the period of this study
• history of gastric, digestive, cardiovascular, renal disease or any other orthopaedic diseases related to motor organs
• lidocaine allergy
• use of medication that may affect study measures
• contraindication to the biopsy procedures
• on medications that affect the immune system
• on Aspirin or other drugs known to prolong bleeding
• smoker
• user of dietary supplements currently or in the past one month
• a heavy drinker

Sponsors & Collaborators

• Loughborough University: lead
• Kyowa Hakko Bio Co., Ltd.: collaborator

Study Sites (1)

School of Sport, Exercise and Health Sciences

Loughborough, Leicester, Le11 3YU, United Kingdom

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Stephen J Bailey, PhD

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Sport ad Exercise Nutrition

Model Details: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 26, 2019
• Study Start: May 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

GB (1)