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Aseptic Muscle InjuryPRoNACNCT06367413

Effects of Protein and NAC Co-ingestion on Skeletal Muscle Recovery

A study testing NAC and NAC + Whey Protein in people with Aseptic Muscle Injury, run by University of Thessaly at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of… Read more about this study

Who is it for?
Ages 18 to 27 years, men onlyHealthy volunteers can take part
Conditions the study is for
Aseptic Muscle Injury
What is being tested?
NAC and NAC + Whey Protein
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteGreece
Study dates
8 Apr 2024to 30 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 27 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Free of asthma, kidney disease, bleeding disorders, peptic ulcers.
  • Free of musculoskeletal injuries and limitations.
  • Abstain from dietary energy restriction.
  • Do not use medication such as anti-inflammatory drugs, antibiotics, antihypertensive drugs or anticoagulants.
  • Do not use dietary supplements such as protein, carbohydrate, antioxidants, vitamins etc.
  • Free of N-acetylcysteine intolerance.
  • Non-smokers.
  • Abstain from alcohol throughout the study.

Who cannot join

  • Presence of asthma, kidney disease, bleeding disorders, peptic ulcers.
  • Musculoskeletal injuries and limitations.
  • Dietary energy restriction.
  • Use of anti-inflammatory drugs, antibiotics, antihypertensive drugs or anticoagulants.
  • Use of dietary supplements such as protein, carbohydrate, antioxidants, vitamins etc.
  • N-acetylcysteine intolerance.
  • Smoking.
  • Alcohol consumption during the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dimitrios Draganidis, PhD contact

+30 2431047078

ddraganidis@uth.gr

Ioannis G Fatouros, PhD contact

+302431047047

ifatouros@uth.gr

Greece1 site, 1 recruiting
  • Department of Physical Education and Sport Science, University of Thessaly

    Trikala, Karies, 42100

    Dimitrios Draganidis, PhD, +30 2431047078, ddraganidis@uth.gr

    Ioannis G Fatouros, PhD, +302431047047, ifatouros@uth.gr

    Recruiting

Other trials in Greece

About this study

Official title: Effects of Whey Protein and N-acetylcysteine Co-ingestion on Skeletal Muscle Recovery Following Exercise-induced Muscle Damage.

Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of recovery. The enhanced performance capacity during the first phase of recovery in response to NAC supplementation might be attributed to the altered redox status in skeletal muscle as a consequence of the NAC-mediated elevation of reduced glutathione (GSH) levels. The rise in GSH results in a redox-dependent attenuation of immune cell mobilisation and reduction of oxidative stress response, leading to a blunted rise of muscle damage and inflammatory markers during the first 2-3 days of recovery. However, following exercise-induced muscle damage, protein synthesis increases in skeletal muscle over the next 24-48 hours to support its repair process, and thus protein supplementation might accelerate the recovery process by enhancing the protein synthetic response. Therefore, the present study aims at investigating for first time the combined effect of NAC and whey protein supplementation on the short-term (during the first 72 hours) recovery process of skeletal muscle following damaging exercise (eccentric exercise) and compared it with the well-documented efficacy of NAC supplementation. The results of this study might be particularly useful for athletes, such as those in soccer and basketball, that participate in 3 games or intense training sessions during the same macrocycle with only 48-72 hours of recovery in-between.

Read the detailed description

Participants will initially undergo baseline testing including assessment of their (i) anthropometrics, (ii) body composition via DXA, (iii) habitual physical activity level via accelerometry, (iv) resting metabolic rate via indirect calorimetry, (v) daily dietary intake via 7-day dietary recalls and (vi) cardiorespiratory fitness using a treadmill ramp test. After baseline testing, participants will be assigned to (a) a Placebo, (b) a N-acetylcysteine (NAC) or (c) a N-acetylcysteine + Whey protein (PRoNAC) group, in a randomized, double-blind, placebo-controlled, parallel group, repeated measures design. In all groups, participants will execute an eccentric exercise protocol on an isokinetic dynamometer consisted of 150 eccentric muscle contractions. Before exercise as well as at 1-, 2-, 3-, 24-, 48- and 72-hours post-exercise they will undergo assessment of their maximal voluntary isometric peal torque, maximal countermovement jump height and muscle soreness level. In addition, blood sample will be drawn before exercise and at 24-, 48- and 72-hours post-exercise for the determination of myoglobin concentration, reduced (GSH) and oxidized (GSSG) glutathione content, protein carbonyl formation and catalase activity.

Throughout the 4-day experimental period (Day 1: exercise day, Days 2, 3 and 4: 24-, 48- and 72-hours post-exercise, respectively) participants will receive daily, 3 doses from the respective supplement as follows: the 1st dose at mid-morning (between breakfast and lunch), the 2nd dose at mid-afternoon (post-exercise on day 1 and between lunch and dinner on days 2-4) and the 3rd dose before sleep. In Placebo group, participants will be supplemented with 0.31 gr of maltodextrin per kg of body weight in the first two servings (at mid-morning and mid-afternoon supplements) and with 0.49 gr of maltodextrin per kg of body weight in the pre-sleep serving (1.1 gr maltodextrin/kg BW/day). In NAC group, participants will be supplemented with 13.33 mg of N-acetylcysteine per kg of body weight per serving (40 mg NAC/kg BW/day). In PRoNAC group participants will be supplemented with 0.31 gr of whey protein and 13.33 mg of N-acetylcysteine per kg of body weight in the first two servings (at mid-morning and mid-afternoon supplements) and with 0.49 gr of whey protein and 13.33 mg of N-acetylcysteine per kg of body weight in the pre-sleep serving (1.1 gr Whey protein + 40 mg NAC /kg BW/day).

Being tested
Placebo, NAC, NAC + Whey Protein

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    Participants will receive three servings of carbohydrate per day during the 4-day experimental period. In specific, they will be supplemented with 0.31 gr of maltodextrin per kg of body weight in the first two servings (at mid-morning and mid-afternoon supplements) and with 0.49 gr of maltodextrin per kg of body weight in the pre-sleep serving (1.1 gr maltodextrin/kg BW/day).

  • NACDietary supplement

    Participants will receive three servings of N-acetylcysteine per day during the 4-day experimental period. In specific, they will be supplemented with 13.33 mg of N-acetylcysteine per kg of body weight per serving (40 mg NAC/kg BW/day).

  • NAC + Whey ProteinDietary supplement

    Participants will receive three servings of N-acetylcysteine + whey protein per day during the 4-day experimental period. In specific, they will be supplemented with 0.31 gr of whey protein and 13.33 mg of N-acetylcysteine per kg of body weight in the first two servings (at mid-morning and mid-afternoon supplements) and with 0.49 gr of whey protein and 13.33 mg of N-acetylcysteine per kg of body weight in the pre-sleep serving (1.1 gr Whey protein + 40 mg NAC /kg BW/day).

Study groups in NCT06367413
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants in this arm will execute 150 eccentric muscle contractions an receive a placebo supplement consisted of carbohydrate (maltodextrin).
Receives: Dietary Supplement: Placebo
NACExperimentalParticipants in this arm will execute 150 eccentric muscle contractions an receive a N-acetylcysteine supplement.
Receives: Dietary Supplement: NAC
PRoNACExperimentalParticipants in this arm will execute 150 eccentric muscle contractions an receive a supplement consisted of N-acetylcysteine and whey protein.
Receives: Dietary Supplement: NAC + Whey Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in maximal voluntary isometric muscle contraction.

    Maximal voluntary isometric muscle contraction will be assessed on an isokinetic dynamometer.

    Measured: Before exercise and at 1-, 2-, 3-, 24-, 48- and 72-hours post-exercise.

  2. Change in countermovement jump height.

    Countermovement jump height will be assessed by using the Optojump Next system.

    Measured: Before exercise and at 1-, 2-, 3-, 24-, 48- and 72-hours post-exercise.

  3. Change in delayed onset of muscle soreness (DOMS)

    DOMS of the knee extensors of the dominant limb will be evaluated by palpation of the relaxed muscle's belly and distal region with participants rating the perceived soreness on a visual analogue scale ranging from 1 to 10.

    Measured: Before exercise and at 1-, 2-, 3-, 24-, 48- and 72-hours post-exercise.

  4. Change in reduced glutathione content.

    Reduced glutathione content in blood erythrocytes will be assessed using spectrophometric method.

    Measured: Before exercise and at 24-, 48- and 72-hours post-exercise.

  5. Change in oxidized glutathione content.

    Oxidized glutathione content in blood erythrocytes will be assessed using spectrophometric method.

    Measured: Before exercise and at 24-, 48- and 72-hours post-exercise.

  6. Change in catalase activity.

    Catalase activity will be measured spectrophotometrically in red blood cells.

    Measured: Before exercise and at 24-, 48- and 72-hours post-exercise.

  7. Change in protein carbonyl concentration

    Protein carbonyl concentration will be measured spectrophotometrically in red blood cells.

    Measured: Before exercise and at 24-, 48- and 72-hours post-exercise.

  8. Change in myoglobin concentration in blood.

    Myoglobin concentration in blood will be assessed using an automatic biochemistry analyzer and commercially available kits.

    Measured: Before exercise and at 24-, 48- and 72-hours post-exercise.

Secondary outcomes (8)
  1. Participants' lean body mass

    Lean body mass (kg) will be assessed using dual-energy X-ray absorptiometry (DXA) instrumentation.

    Measured: At baseline.

  2. Participants' daily physical activity-related energy expenditure.

    Physical activity-related energy expenditure (kcal/day) will be assessed using accelerometers.

    Measured: At baseline.

  3. Participants daily dietary intake.

    Daily dietary intake composition (total kcal/day, gr of protein, gr of CHO and gr of fat intake/day, gr/mg of micronutrient intake/day) will be monitored using 24-h dietary recalls that will be analyzed by a trained dietitian using a dietary analysis software.

    Measured: At baseline.

  4. Participants' resting metabolic rate.

    Resting metabolic rate will be assessed using indirect calorimetry.

    Measured: At baseline.

  5. Participants' cardiorespiratory fitness status.

    Cardiorespiratory fitness will be assessed using a treadmill ramp test.

    Measured: At baseline.

  6. Participants' fat free mass.

    Fat free mass will be assessed using dual-energy X-ray absorptiometry (DXA) instrumentation.

    Measured: At baseline.

  7. Participants' fat mass.

    Fat mass will be assessed using dual-energy X-ray absorptiometry (DXA) instrumentation.

    Measured: At baseline.

  8. Participants' body fat percent.

    Body fat percent (%) will be assessed using dual-energy X-ray absorptiometry (DXA) instrumentation.

    Measured: At baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2024
  2. Study start8 Apr 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, double-blind, placebo-controlled, parallel group model.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06367413
Sponsor's protocol ID
UTH-PRoNAC Study
Acronym
PRoNAC
Status last verified
Jan 2025
First submitted
7 Apr 2024
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing NAC and NAC + Whey Protein in people with Aseptic Muscle Injury, run by University of Thessaly at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dimitrios Draganidis, PhD (+30 2431047078, ddraganidis@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in maximal voluntary isometric muscle contraction. (time frame: Before exercise and at 1-, 2-, 3-, 24-, 48- and 72-hours post-exercise.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

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