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

NCT ID: NCT03998800

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-01-01

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.

Detailed Description

This study is a randomized, double-blind, cross over trial of L-arginine and L-citrulline supplementation, L-arginine supplementation alone and placebo supplementation in healthy men. The intervention period will be 8-11 weeks for each participant and a minimum of 15 individuals will be recruited and enrolled to complete the trial. Subjects will complete the experimental protocol described below over 3 individual 10 day supplementation periods, separated by washout periods of approximately 2 weeks. Subjects will ingest corn-starch as a placebo, L-arginine (3g/day) or L-arginine (1.5 g/day) + L-citrulline (1.5g/day). On day 7 of the supplementation period, a skeletal muscle biopsy and blood sample will be obtained from the subjects to investigate mitochondrial function and blood amino acid and nitric oxide levels. On day 10 of the supplementation period, subjects will complete a performance test on a cycle ergometer to investigate their endurance performance. These assessments will be performed to determine the effects of co-ingesting L-arginine and L-citrulline compared to L-arginine alone and placebo administration.

Conditions

Dietary Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

L-arginine and L-citrulline

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

Group Type: EXPERIMENTAL

Dietary Supplement

Intervention Type: 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.

Endurance exercise on a cycle ergometer

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Dietary Supplement

Intervention Type: 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.

Endurance exercise on a cycle ergometer

Intervention Type: BEHAVIORAL

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

Placebo (corn-starch)

10 days of supplementation with corn-starch

Group Type: PLACEBO_COMPARATOR

Dietary Supplement

Intervention Type: 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.

Endurance exercise on a cycle ergometer

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Endurance exercise on a cycle ergometer

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Hakko Bio Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Stephen Bailey

Lecturer in Sport ad Exercise Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen J Bailey, PhD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

School of Sport, Exercise and Health Sciences

Loughborough, Leicester, United Kingdom

Countries

United Kingdom

Other Identifiers

R19-P010

Identifier Type: -

Identifier Source: org_study_id