Redox Status and Immune Function

NCT02930031 | Completed DMC

• 1 other identifier: NACEXERCISE2016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this investigation the investigators utilized N-acetylcysteine (NAC) supplementation to enhance reduced glutathione (GSH) stores during an 8-day recovery period from a strenuous eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may alter immune cell responses following exercise-induced muscle microtrauma.

Conditions

Skeletal Muscle Damage; Aseptic Inflammation; Skeletal Muscle Function

Keywords

muscle injury; exercise; redox status; immune cells

Outcome Measures

Primary Outcomes (25)

• Changes in protein carbonyls in red blood cells

  Concentration of protein carbonyls

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in thiobarbituric acid reactive substances in red blood cells

  Thiobarbituric acid reactive substances concentration in red blood cells

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in total antioxidant capacity in serum

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in reduced glutathione in blood

  Concentration of reduced glutathione in red blood cells

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in oxidized glutathione in blood

  Concentration of oxidized glutathione in red blood cells

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in catalase activity in red blood cells

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in creatine kinase activity in serum

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in high sensitivity C-reactive protein in serum

  Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise

• Changes in white blood cell count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in adhesion molecule concentration in blood

  Measurement of soluble vascular cell adhesion molecule-1 (sVCAM-1) and soluble intercellular cell adhesion molecule-1 (sICAM-1) concentrations in plasma

  Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise

• Changes in cytokine concentration in serum

  Measurement of interleukin-1β (IL-1β) and interleukin-6 (IL-6)

  Pre-exercise, 2 hours post-exercise, 1 day post-exercise, 2 days post-exercise, 3 days post-exercise, 8 days post-exercise

• Changes in neutrophil count in blood

  Cytofluorometric analysis of neutrophil count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in lymphocyte count in blood

  Cytofluorometric analysis of lymphocyte count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in monocyte count in blood

  Cytofluorometric analysis of monocyte count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in basophil count in blood

  Cytofluorometric analysis of baseophil count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in eosinophil count in blood

  Cytofluorometric analysis of eosinophil count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in T-helper cell count in blood

  Cytofluorometric analysis of T-helper cell count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in T cytotoxic cell count in blood

  Cytofluorometric analysis of T cytotoxic cell count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in natural killer-T (NK-T) cell count in blood

  Cytofluorometric analysis of NK-T cell count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in 62L macrophage count in blood

  Cytofluorometric analysis of 62L macrophage count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in B lympho cell count in blood

  Cytofluorometric analysis of B lympho cell count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in natural killer (NK) cell count in blood

  Cytofluorometric analysis of natural killer cell count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in macrophage count in blood

  Cytofluorometric analysis of macrophage count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in HLA+/Macr+ macrophage count in blood

  Cytofluorometric analysis of HLA+/Macr+ count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in 11B+ macrophage count in blood

  Cytofluorometric analysis of 11B+ macrophage count in blood

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

Secondary Outcomes (5)

• Changes in muscle performance

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Changes in delayed onset of muscle soreness

  Pre-exercise, 2 hours post-exercise, daily for 8 consecutive days post-exercise

• Maximal aerobic capacity

  One day before exercise

• Body composition

  One day before exercise

• Changes in dietary intake profile

  One day before exercise and daily for 8 consecutive days post-exercise

Study Arms (2)

n-acetylcysteine

EXPERIMENTAL

orally in three daily dosages, at 20 mg/kg/day, daily for eight days after exercise

Dietary Supplement: n-acetylcysteine

Placebo

ACTIVE COMPARATOR

orally in three daily dosages, content: 500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder

Dietary Supplement: Placebo

Interventions

n-acetylcysteine DIETARY_SUPPLEMENT

20 mg//kg/day, orally, daily for eight days following exercise

Also known as: NAC

n-acetylcysteine

Placebo DIETARY_SUPPLEMENT

500 mL orally, daily for eight days following exercise

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Recreationally trained (VO2max \> 45 ml/kg/min)
• Engaged in regular exercise for ≥3 times/week for \> 12 months
• non-smokers
• Abstain from exercise during the course of the two trials
• No consumption of performance-enhancing substances, antioxidants, caffeine, alcohol and/or medications during the study.

You may not qualify if:

• NAC intolerance
• Recent musculoskeletal injuries of the lower limbs
• Febrile illness
• History of muscle lesion.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

University of Athens, Medical School, Department of Clinical Therapeutics

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Asimina Mitrakou, Associate Prof.

  Department of Diabetes and Metabolism Unit of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens

  STUDY DIRECTOR

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: PhD candidate in Department of Diabetes and Metabolism Unit

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 11, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

GR (1)