Dietary SupplementsNCT06511960
Effects of Astaxanthin Supplementation
A study testing Astaxanthin (12 mg/day) intervention and 36 mg/day astaxanthin intervention in people with Dietary Supplements, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Astaxanthin is a potent antioxidant and anti-inflammatory carotenoid. Research examining whether astaxanthin (AX) could counteract exercise-induced muscle damage and improve exercise capacity reported inconsistent results.Therefore, the aim of this study was to explore the impact of 4 weeks supplementation with AX on… Read more about this study
- Who is it for?
- Ages 19 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplements
- What is being tested?
- Astaxanthin (12 mg/day) intervention and 36 mg/day astaxanthin intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males engaging in recreational activity Aged between 20 and 30 years Non-smoker Not participating in any structured training regimen (i.e., endurance or resistance training programs)
Who cannot join
- Use of any supplement or regular medications, Having hypothyroidism or hyperthyroidism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Four Weeks of Astaxanthin Supplementation at Varied Doses on Muscle Pain, Muscle Damage Markers, and Total Antioxidant Status in Exercising Males: A Randomized Controlled Trial
Astaxanthin is a potent antioxidant and anti-inflammatory carotenoid. Research examining whether astaxanthin (AX) could counteract exercise-induced muscle damage and improve exercise capacity reported inconsistent results.Therefore, the aim of this study was to explore the impact of 4 weeks supplementation with AX on muscle damage markers, total antioxidant status, and subjective marker of muscle pain. Twenty-four males were randomly assigned to the AX12 group (12 mg/day; n=8), AX36 group (36 mg/day; n=9), or placebo group (PLC; n=7). After 4 weeks of supplementation, blood samples were collected at rest, immediately after, and at 2, 24, 48, and 72 hours following eccentric arm exercise at 85% of predetermined one repetition maximum to assess muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10.
Read the detailed description
This study followed a placebo-controlled, double-blind (participants and co-researcher administering the supplementation), and three-group parallel design to examine the effects of an AX supplement on muscle pain, muscle damage markers, and total antioxidant status (TAS).
Participants reported to the laboratory on 2 separate occasions: one initial session to measure anthropometrics and 1-repetition maximum (1RM) strength of the arm muscles and as well as to collect resting venous blood samples, prior to the four-week supplementation period. Upon arrival at the laboratory for their initial visits, each participant underwent measurements of body mass (MC 780 ST Black) and body height (Telescopic Height Meter), after which resting venous blood samples were collected from the median antecubital vein by a healthcare professional.
Following these baseline measurements, participants were assigned to one of the groups through a strict randomization process, which included selecting boxes numbered up to 24, all with the same size, color, and pattern. Participants were asked to choose one of the random numbers accompanied by an independent person other than the researchers. This process was recorded by the supervisor in paper-based surveys and digitally. Subsequently, all participants were instructed to consume their corresponding supplements (4 mg/day AX, 12 mg/day AX or 12 mg/day PLC) for 4 weeks.
After the 4 weeks of supplementation, participants reported to the laboratory for the post-supplementation measurements that included the collection of blood samples at rest, immediately after, as well as at 2, 24, 48, and 72 hours following completing eccentric arm exercises performed at 85% of predetermined 1RM.
Before obtaining blood samples (i.e., immediately after, and at 2, 24, 48, and 72 hours after exercises), participants were asked to assess their current pain levels using the Numerical Visual Pain Scale (NRS, ranging between 0-10 and 0-100) to determine any correspondence with muscle damage markers in the blood 25.
All participants were instructed to abstain from taking any medications for a minimum of 7 days prior to the study and to avoid consuming vitamins, foods, or supplements containing antioxidants, as well as analgesics, aspirin, or any other anti-inflammatory drugs throughout the duration of the study. A list of AX-rich foods, beverages and vitamins was provided to each participant prior to testing and all participants were asked to avoid these items during both 4-week supplementation periods and to maintain their regular eating habits and refrain from strenuous exercise to minimize the risk of muscle damage. A WhatsApp group was created for the purpose of monitoring the participants' supplement use.
To ascertain the extent of product usage, a survey form created using Google Forms was disseminated during the supplementation period. Participants were required to approve the form on a daily basis. At the end of each day, the data entered into the Excel file created using OneDrive was reviewed by at least one researcher.
- Conditions
- Dietary Supplements
- Being tested
- Astaxanthin (12 mg/day) intervention, 36 mg/day astaxanthin intervention, Placebo
- Keywords
- Astaxanthin, supplements, antioxidant, muscle damage, resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin (12 mg/day) interventionOther
12 mg/day astaxanthin was administrated to all participants in the astaxanthin 12 mg/day groupfor 4 weeks. Following this supplementation protocol, we assessed the muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10.
36 mg/day astaxanthin interventionOther
36 mg/day astaxanthin was administrated to all participants in the astaxanthin 36 mg/day group for 4 weeks. Following this supplementation protocol, we assessed the muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10.
PlaceboOther
12 mg/day placebo was administrated to all participants in the placebo group for 4 weeks. Following the placebo supplementation, we assessed the muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10.
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin (12 mg/day) group | Active comparator | In this group, participants ingested either 12 mg/day (AX12) for 4 weeks. Receives: Other: Astaxanthin (12 mg/day) intervention |
| Astaxanthin (36 mg/day) group | Active comparator | In this group, participants ingested either 36 mg/day (AX36) for 4 weeks. Receives: Other: 36 mg/day astaxanthin intervention |
| Placebo | Placebo comparator | In this group, participants ingested the placebo capsules that were identical in appearance and dimensions to the astaxanthin supplement. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Muscle Pain
The pain sensation in the participants' elbow extensor and elbow flexor muscles was assessed using the NRS. NRS is one of the most widely used scales due to its simplicity and effectiveness for assessing pain intensity across various medical settings and research studies. This scale rates individuals' pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable (1-3: mild pain, 4-6: moderate pain, 7-10: severe pain). In this study, we evaluated the participants' pain immediately after exercise and at 2, 24, 48, and 72 hours post-exercise. For this, participants were instructed to move their arms, which were used in the 1RM eccentric arm exercise, from a fully bent position to a fully straight position. During this movement, participants were asked to rate the intensity of pain they experienced.
Measured: 2-6 months
Assessment of Malondialdehyde (MDA)
MDA is a natural product of lipid peroxidation. Lipid peroxidation is a well-known mechanism of animal and plant cell damage and suggests the level of oxidative stress or damage in cells and tissues. The MDA levels were assessed using thiobarbituric acid reactive substances assay kits (Cayman TBARS, Cayman Chemical, Ann Arbor, Michigan, USA, item no. 10009055) based on the trichloroacetic acid method in accordance with the manufacturer's instructions. The absorbance measurements were taken using the ChemWell 2910 ELISA reader device (Awareness, Technology, Inc. Martin Hwy. Palm City, USA). The results were presented as mmol Trolox Equiv./L for TAS and µM for MDA.
Measured: 2-6 months
Assessment of Total Antioxidant Status (TAS)
Serum TAS (mmol Trolox Equiv./L) was determined using the Rel Assay Diagnostics kit (Mega Tip, Gaziantep, Turkey) using the method developed by Erel. This method mediates the production of a hydroxyl radical. The hydroxyl radical is the most powerful among biological radicals. In the test, the Fe ion solution present in reagent 1 is mixed with hydrogen peroxide present in reagent 2. Using this method, the antioxidative effect of the sample against the strong free radical reactions initiated by the hydroxyl radical produced was measured. The test had excellent sensitivity values of > 97%. Results were expressed as millimoles of Trolox equivalents per liter (mmol Trolox Equiv./L).
Measured: 2-6 months
Assessment of Muscle Damage Markers: Creatine kinase (CK) and Lactate Dehydrogenase (LDH)
Serum CK and LDH were analyzed on a fully automatic analyzer (Roche Cobas Integra 400 Plus, Roche Diagnostics GmbH, Mannheim, Germany) using ROCHE kits (Mannheim, Germany). Data were calculated using linear regression and measurements were taken at 550 nm.
Measured: 2-6 months
Assessment of Uric Acid
Uric acid were analyzed on a fully automatic analyzer (Roche Cobas Integra 400 Plus, Roche Diagnostics GmbH, Mannheim, Germany) using ROCHE kits (Mannheim, Germany). Data were calculated using linear regression and measurements were taken at 550 nm.
Measured: 2-6 months
Secondary outcomes (1)
Measurement of One-Repetition Maximum (1RM) Arm Strength
The 1RM arm strength of participants was quantified by measuring the number of biceps curl repetitions performed in a seated position, following a 10-repetition warm-up set with a load equivalent to 50% of the estimated 1RM based on the participants' experience. Following a one-minute recovery period, a first set of five repetitions was performed at 75% of 1RM. After a two-minute recovery period, a second set of three repetitions was performed at approximately 90% of 1RM. Finally, after a 4-minute recovery, incremental increases of 2.5 kg were applied for each subsequent 1RM attempt until failure. After 4 weeks of supplementation, all participants performed an eccentric arm exercise of 10 sets × 10 repetitions at 85% of 1RM, with 3-minute passive rest intervals between each set, following a 10-repetition warm-up with 50% of 1RM.
Measured: 1-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Sep 2023
- Primary completion1 Jan 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, double-blind and three-group parallel design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Mustafa Atakan, Hacettepe University
- Investigators
- Muhammed Atakan, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511960
- Sponsor's protocol ID
- IMU-GETAT-E-95961207
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howatson G, van Someren KA. The prevention and treatment of exercise-induced muscle damage. Sports Med. 2008;38(6):483-503. doi: 10.2165/00007256-200838060-00004.
PubMed 18489195Markus I, Constantini K, Hoffman JR, Bartolomei S, Gepner Y. Exercise-induced muscle damage: mechanism, assessment and nutritional factors to accelerate recovery. Eur J Appl Physiol. 2021 Apr;121(4):969-992. doi: 10.1007/s00421-020-04566-4. Epub 2021 Jan 8.
PubMed 33420603Bloomer RJ. The role of nutritional supplements in the prevention and treatment of resistance exercise-induced skeletal muscle injury. Sports Med. 2007;37(6):519-32. doi: 10.2165/00007256-200737060-00005.
PubMed 17503877McArdle A, Vasilaki A, Jackson M. Exercise and skeletal muscle ageing: cellular and molecular mechanisms. Ageing Res Rev. 2002 Feb;1(1):79-93. doi: 10.1016/s0047-6374(01)00368-2.
PubMed 12039450Vina J, Gomez-Cabrera MC, Lloret A, Marquez R, Minana JB, Pallardo FV, Sastre J. Free radicals in exhaustive physical exercise: mechanism of production, and protection by antioxidants. IUBMB Life. 2000 Oct-Nov;50(4-5):271-7. doi: 10.1080/713803729.
PubMed 11327321He F, Li J, Liu Z, Chuang CC, Yang W, Zuo L. Redox Mechanism of Reactive Oxygen Species in Exercise. Front Physiol. 2016 Nov 7;7:486. doi: 10.3389/fphys.2016.00486. eCollection 2016.
PubMed 27872595Kuru D, Aktitiz S, Atakan MM, Kose MG, Turnagol HH, Kosar SN. Effect of Pre-exercise Sodium Citrate Ingestion on Repeated Sprint Performance in Soccer Players. J Strength Cond Res. 2024 Mar 1;38(3):556-562. doi: 10.1519/JSC.0000000000004651. Epub 2024 Jan 19.
PubMed 38241467Bongiovanni T, Genovesi F, Nemmer M, Carling C, Alberti G, Howatson G. Nutritional interventions for reducing the signs and symptoms of exercise-induced muscle damage and accelerate recovery in athletes: current knowledge, practical application and future perspectives. Eur J Appl Physiol. 2020 Sep;120(9):1965-1996. doi: 10.1007/s00421-020-04432-3. Epub 2020 Jul 13.
PubMed 32661771Brotosudarmo THP, Limantara L, Setiyono E, Heriyanto. Structures of Astaxanthin and Their Consequences for Therapeutic Application. Int J Food Sci. 2020 Jul 20;2020:2156582. doi: 10.1155/2020/2156582. eCollection 2020.
PubMed 32775406Higuera-Ciapara I, Felix-Valenzuela L, Goycoolea FM. Astaxanthin: a review of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. doi: 10.1080/10408690590957188.
PubMed 16431409Cao Y, Yang L, Qiao X, Xue C, Xu J. Dietary astaxanthin: an excellent carotenoid with multiple health benefits. Crit Rev Food Sci Nutr. 2023;63(18):3019-3045. doi: 10.1080/10408398.2021.1983766. Epub 2021 Sep 28.
PubMed 34581210Brown DR, Gough LA, Deb SK, Sparks SA, McNaughton LR. Astaxanthin in Exercise Metabolism, Performance and Recovery: A Review. Front Nutr. 2018 Jan 18;4:76. doi: 10.3389/fnut.2017.00076. eCollection 2017.
PubMed 29404334Waldman HS, Bryant AR, Parten AL, Grozier CD, McAllister MJ. Astaxanthin Supplementation Does Not Affect Markers of Muscle Damage or Inflammation After an Exercise-Induced Muscle Damage Protocol in Resistance-Trained Males. J Strength Cond Res. 2023 Jul 1;37(7):e413-e421. doi: 10.1519/JSC.0000000000004408. Epub 2023 Jan 18.
PubMed 36727984Naguib YM. Antioxidant activities of astaxanthin and related carotenoids. J Agric Food Chem. 2000 Apr;48(4):1150-4. doi: 10.1021/jf991106k.
PubMed 10775364
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Four Weeks of Astaxanthin Supplementation at Varied Doses on Muscle Pain, Muscle Damage Markers, and Total Antioxidant Status in Exercising Males: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06511960
- Acronym / sponsor ID
- IMU-GETAT-E-95961207
- Conditions
- Dietary Supplements
- Keywords
- Astaxanthin, supplements, antioxidant, muscle damage, resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Astaxanthin is a potent antioxidant and anti-inflammatory carotenoid. Research examining whether astaxanthin (AX) could counteract exercise-induced muscle damage and improve exercise capacity reported inconsistent results.Therefore, the aim of this study was to explore the impact of 4 weeks supplementation with AX on muscle damage markers, total antioxidant status, and subjective marker of muscle pain. Twenty-four males were randomly assigned to the AX12 group (12 mg/day; n=8), AX36 group (36 mg/day; n=9), or placebo group (PLC; n=7). After 4 weeks of supplementation, blood samples were collected at rest, immediately after, and at 2, 24, 48, and 72 hours following eccentric arm exercise at 85% of predetermined one repetition maximum to assess muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10.
Detailed description
This study followed a placebo-controlled, double-blind (participants and co-researcher administering the supplementation), and three-group parallel design to examine the effects of an AX supplement on muscle pain, muscle damage markers, and total antioxidant status (TAS).
Participants reported to the laboratory on 2 separate occasions: one initial session to measure anthropometrics and 1-repetition maximum (1RM) strength of the arm muscles and as well as to collect resting venous blood samples, prior to the four-week supplementation period. Upon arrival at the laboratory for their initial visits, each participant underwent measurements of body mass (MC 780 ST Black) and body height (Telescopic Height Meter), after which resting venous blood samples were collected from the median antecubital vein by a healthcare professional.
Following these baseline measurements, participants were assigned to one of the groups through a strict randomization process, which included selecting boxes numbered up to 24, all with the same size, color, and pattern. Participants were asked to choose one of the random numbers accompanied by an independent person other than the researchers. This process was recorded by the supervisor in paper-based surveys and digitally. Subsequently, all participants were instructed to consume their corresponding supplements (4 mg/day AX, 12 mg/day AX or 12 mg/day PLC) for 4 weeks.
After the 4 weeks of supplementation, participants reported to the laboratory for the post-supplementation measurements that included the collection of blood samples at rest, immediately after, as well as at 2, 24, 48, and 72 hours following completing eccentric arm exercises performed at 85% of predetermined 1RM.
Before obtaining blood samples (i.e., immediately after, and at 2, 24, 48, and 72 hours after exercises), participants were asked to assess their current pain levels using the Numerical Visual Pain Scale (NRS, ranging between 0-10 and 0-100) to determine any correspondence with muscle damage markers in the blood 25.
All participants were instructed to abstain from taking any medications for a minimum of 7 days prior to the study and to avoid consuming vitamins, foods, or supplements containing antioxidants, as well as analgesics, aspirin, or any other anti-inflammatory drugs throughout the duration of the study. A list of AX-rich foods, beverages and vitamins was provided to each participant prior to testing and all participants were asked to avoid these items during both 4-week supplementation periods and to maintain their regular eating habits and refrain from strenuous exercise to minimize the risk of muscle damage. A WhatsApp group was created for the purpose of monitoring the participants' supplement use.
To ascertain the extent of product usage, a survey form created using Google Forms was disseminated during the supplementation period. Participants were required to approve the form on a daily basis. At the end of each day, the data entered into the Excel file created using OneDrive was reviewed by at least one researcher.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Placebo-controlled, double-blind and three-group parallel design
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin (12 mg/day) group | Active comparator | Other: Astaxanthin (12 mg/day) interventionIn this group, participants ingested either 12 mg/day (AX12) for 4 weeks. |
| Astaxanthin (36 mg/day) group | Active comparator | Other: 36 mg/day astaxanthin interventionIn this group, participants ingested either 36 mg/day (AX36) for 4 weeks. |
| Placebo | Placebo comparator | Other: PlaceboIn this group, participants ingested the placebo capsules that were identical in appearance and dimensions to the astaxanthin supplement. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males engaging in recreational activity Aged between 20 and 30 years Non-smoker Not participating in any structured training regimen (i.e., endurance or resistance training programs)
Key exclusion criteria (1 listed)
- Use of any supplement or regular medications, Having hypothyroidism or hyperthyroidism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astaxanthin (12 mg/day) intervention12 mg/day astaxanthin was administrated to all participants in the astaxanthin 12 mg/day groupfor 4 weeks. Following this supplementation protocol, we assessed the muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10. | Other | Astaxanthin (12 mg/day) group |
| 36 mg/day astaxanthin intervention36 mg/day astaxanthin was administrated to all participants in the astaxanthin 36 mg/day group for 4 weeks. Following this supplementation protocol, we assessed the muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10. | Other | Astaxanthin (36 mg/day) group |
| Placebo12 mg/day placebo was administrated to all participants in the placebo group for 4 weeks. Following the placebo supplementation, we assessed the muscle damage markers (creatine kinase and lactate dehydrogenase), total antioxidant status (malondialdehyde and uric acid), and muscle pain levels were evaluated using the Numerical Visual Pain Scale0-10. | Other | Placebo |
Primary outcome
Assessment of Muscle Pain
Time frame: 2-6 months
The pain sensation in the participants' elbow extensor and elbow flexor muscles was assessed using the NRS. NRS is one of the most widely used scales due to its simplicity and effectiveness for assessing pain intensity across various medical settings and research studies. This scale rates individuals' pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable (1-3: mild pain, 4-6: moderate pain, 7-10: severe pain). In this study, we evaluated the participants' pain immediately after exercise and at 2, 24, 48, and 72 hours post-exercise. For this, participants were instructed to move their arms, which were used in the 1RM eccentric arm exercise, from a fully bent position to a fully straight position. During this movement, participants were asked to rate the intensity of pain they experienced.
Assessment of Malondialdehyde (MDA)
Time frame: 2-6 months
MDA is a natural product of lipid peroxidation. Lipid peroxidation is a well-known mechanism of animal and plant cell damage and suggests the level of oxidative stress or damage in cells and tissues. The MDA levels were assessed using thiobarbituric acid reactive substances assay kits (Cayman TBARS, Cayman Chemical, Ann Arbor, Michigan, USA, item no. 10009055) based on the trichloroacetic acid method in accordance with the manufacturer's instructions. The absorbance measurements were taken using the ChemWell 2910 ELISA reader device (Awareness, Technology, Inc. Martin Hwy. Palm City, USA). The results were presented as mmol Trolox Equiv./L for TAS and µM for MDA.
Assessment of Total Antioxidant Status (TAS)
Time frame: 2-6 months
Serum TAS (mmol Trolox Equiv./L) was determined using the Rel Assay Diagnostics kit (Mega Tip, Gaziantep, Turkey) using the method developed by Erel. This method mediates the production of a hydroxyl radical. The hydroxyl radical is the most powerful among biological radicals. In the test, the Fe ion solution present in reagent 1 is mixed with hydrogen peroxide present in reagent 2. Using this method, the antioxidative effect of the sample against the strong free radical reactions initiated by the hydroxyl radical produced was measured. The test had excellent sensitivity values of > 97%. Results were expressed as millimoles of Trolox equivalents per liter (mmol Trolox Equiv./L).
Assessment of Muscle Damage Markers: Creatine kinase (CK) and Lactate Dehydrogenase (LDH)
Time frame: 2-6 months
Serum CK and LDH were analyzed on a fully automatic analyzer (Roche Cobas Integra 400 Plus, Roche Diagnostics GmbH, Mannheim, Germany) using ROCHE kits (Mannheim, Germany). Data were calculated using linear regression and measurements were taken at 550 nm.
Assessment of Uric Acid
Time frame: 2-6 months
Uric acid were analyzed on a fully automatic analyzer (Roche Cobas Integra 400 Plus, Roche Diagnostics GmbH, Mannheim, Germany) using ROCHE kits (Mannheim, Germany). Data were calculated using linear regression and measurements were taken at 550 nm.
1 secondary outcome
Measurement of One-Repetition Maximum (1RM) Arm Strength
Time frame: 1-5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 18489195Howatson G, van Someren KA. The prevention and treatment of exercise-induced muscle damage. Sports Med. 2008;38(6):483-503. doi: 10.2165/00007256-200838060-00004.
- Background: PubMed 33420603Markus I, Constantini K, Hoffman JR, Bartolomei S, Gepner Y. Exercise-induced muscle damage: mechanism, assessment and nutritional factors to accelerate recovery. Eur J Appl Physiol. 2021 Apr;121(4):969-992. doi: 10.1007/s00421-020-04566-4. Epub 2021 Jan 8.
- Background: PubMed 17503877Bloomer RJ. The role of nutritional supplements in the prevention and treatment of resistance exercise-induced skeletal muscle injury. Sports Med. 2007;37(6):519-32. doi: 10.2165/00007256-200737060-00005.
- Background: PubMed 12039450McArdle A, Vasilaki A, Jackson M. Exercise and skeletal muscle ageing: cellular and molecular mechanisms. Ageing Res Rev. 2002 Feb;1(1):79-93. doi: 10.1016/s0047-6374(01)00368-2.
- Background: PubMed 11327321Vina J, Gomez-Cabrera MC, Lloret A, Marquez R, Minana JB, Pallardo FV, Sastre J. Free radicals in exhaustive physical exercise: mechanism of production, and protection by antioxidants. IUBMB Life. 2000 Oct-Nov;50(4-5):271-7. doi: 10.1080/713803729.
- Background: PubMed 27872595He F, Li J, Liu Z, Chuang CC, Yang W, Zuo L. Redox Mechanism of Reactive Oxygen Species in Exercise. Front Physiol. 2016 Nov 7;7:486. doi: 10.3389/fphys.2016.00486. eCollection 2016.
- Background: PubMed 38241467Kuru D, Aktitiz S, Atakan MM, Kose MG, Turnagol HH, Kosar SN. Effect of Pre-exercise Sodium Citrate Ingestion on Repeated Sprint Performance in Soccer Players. J Strength Cond Res. 2024 Mar 1;38(3):556-562. doi: 10.1519/JSC.0000000000004651. Epub 2024 Jan 19.
- Background: PubMed 32661771Bongiovanni T, Genovesi F, Nemmer M, Carling C, Alberti G, Howatson G. Nutritional interventions for reducing the signs and symptoms of exercise-induced muscle damage and accelerate recovery in athletes: current knowledge, practical application and future perspectives. Eur J Appl Physiol. 2020 Sep;120(9):1965-1996. doi: 10.1007/s00421-020-04432-3. Epub 2020 Jul 13.
- Background: PubMed 32775406Brotosudarmo THP, Limantara L, Setiyono E, Heriyanto. Structures of Astaxanthin and Their Consequences for Therapeutic Application. Int J Food Sci. 2020 Jul 20;2020:2156582. doi: 10.1155/2020/2156582. eCollection 2020.
- Background: PubMed 16431409Higuera-Ciapara I, Felix-Valenzuela L, Goycoolea FM. Astaxanthin: a review of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. doi: 10.1080/10408690590957188.
- Background: PubMed 34581210Cao Y, Yang L, Qiao X, Xue C, Xu J. Dietary astaxanthin: an excellent carotenoid with multiple health benefits. Crit Rev Food Sci Nutr. 2023;63(18):3019-3045. doi: 10.1080/10408398.2021.1983766. Epub 2021 Sep 28.
- Background: PubMed 29404334Brown DR, Gough LA, Deb SK, Sparks SA, McNaughton LR. Astaxanthin in Exercise Metabolism, Performance and Recovery: A Review. Front Nutr. 2018 Jan 18;4:76. doi: 10.3389/fnut.2017.00076. eCollection 2017.
- Individual participant dataSharing planned: No
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Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age
Aging, Muscle Strength
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed Atakan, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin (12 mg/day) intervention and 36 mg/day astaxanthin intervention in people with Dietary Supplements, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jul 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Muscle Pain (time frame: 2-6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06511960, which also lists 14 linked publications.
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 22 Jul 2024.