Effects of Astaxanthin Supplementation

NCT ID: NCT06511960

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-04-15

Brief Summary

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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

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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

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Dietary Supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo-controlled, double-blind and three-group parallel design
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Astaxanthin (12 mg/day) group

In this group, participants ingested either 12 mg/day (AX12) for 4 weeks.

Group Type ACTIVE_COMPARATOR

Astaxanthin (12 mg/day) intervention

Intervention Type OTHER

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.

Astaxanthin (36 mg/day) group

In this group, participants ingested either 36 mg/day (AX36) for 4 weeks.

Group Type ACTIVE_COMPARATOR

36 mg/day astaxanthin intervention

Intervention Type OTHER

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.

Placebo

In this group, participants ingested the placebo capsules that were identical in appearance and dimensions to the astaxanthin supplement.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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Astaxanthin (12 mg/day) intervention

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.

Intervention Type OTHER

36 mg/day astaxanthin intervention

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.

Intervention Type OTHER

Placebo

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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)

Exclusion Criteria

Use of any supplement or regular medications, Having hypothyroidism or hyperthyroidism.
Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Muhammed Mustafa Atakan

Associate Professor of Exercise Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammed Atakan, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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Muhammed Atakan

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 18489195 (View on PubMed)

Markus 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.

Reference Type BACKGROUND
PMID: 33420603 (View on PubMed)

Bloomer 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.

Reference Type BACKGROUND
PMID: 17503877 (View on PubMed)

McArdle 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.

Reference Type BACKGROUND
PMID: 12039450 (View on PubMed)

Vina 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.

Reference Type BACKGROUND
PMID: 11327321 (View on PubMed)

He 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.

Reference Type BACKGROUND
PMID: 27872595 (View on PubMed)

Kuru 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.

Reference Type BACKGROUND
PMID: 38241467 (View on PubMed)

Bongiovanni 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.

Reference Type BACKGROUND
PMID: 32661771 (View on PubMed)

Brotosudarmo 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.

Reference Type BACKGROUND
PMID: 32775406 (View on PubMed)

Higuera-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.

Reference Type BACKGROUND
PMID: 16431409 (View on PubMed)

Cao 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.

Reference Type BACKGROUND
PMID: 34581210 (View on PubMed)

Brown 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.

Reference Type BACKGROUND
PMID: 29404334 (View on PubMed)

Waldman 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.

Reference Type BACKGROUND
PMID: 36727984 (View on PubMed)

Naguib YM. Antioxidant activities of astaxanthin and related carotenoids. J Agric Food Chem. 2000 Apr;48(4):1150-4. doi: 10.1021/jf991106k.

Reference Type BACKGROUND
PMID: 10775364 (View on PubMed)

Other Identifiers

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IMU-GETAT-E-95961207

Identifier Type: -

Identifier Source: org_study_id

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