Redox Status and Immune Function

NCT ID: NCT02930031

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-03-31

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.

Detailed Description

The major thiol-disulfide couple of GSH and oxidized glutathione (GSSG) is a crucial regulator of the main transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. Antioxidant supplementation may hamper exercise-induced inflammatory responses.

The objective was to examine how thiol-based antioxidant supplementation affects immune mobilization following exercise-induced skeletal muscle microtrauma. In a two-trial, double-blind, crossover, repeated measures design, 10 young men received either placebo or NAC (20 mg/kg/day) immediately after a muscle-damaging exercise protocol (300 eccentric contractions) and for eight consecutive days. Blood sampling and performance assessment were performed pre-exercise, 2h post-exercise and daily for 8 consecutive days.

Conditions

Skeletal Muscle Damage; Aseptic Inflammation; Skeletal Muscle Function

Study Design

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

Study Groups

n-acetylcysteine

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

Group Type: EXPERIMENTAL

n-acetylcysteine

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

500 mL orally, daily for eight days following exercise

Interventions

n-acetylcysteine

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

500 mL orally, daily for eight days following exercise

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

NAC

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Alexandra Sakelliou

PhD candidate in Department of Diabetes and Metabolism Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asimina Mitrakou, Associate Prof.

Role: STUDY_DIRECTOR

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

Locations

University of Athens, Medical School, Department of Clinical Therapeutics

Athens, , Greece

Countries

Greece

Other Identifiers

NACEXERCISE2016

Identifier Type: -

Identifier Source: org_study_id