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Lithothamnion Species on Blood Lactate During Exhaustive Exercise in Trained Cyclists (AAPt)

Primary Purpose

Exercise-Induced Lactic Acidemia, Lactate Blood Increase

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mineral Rich Algae
Orange flavoured water with maltodextrin as the placebo
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise-Induced Lactic Acidemia focused on measuring Mineral Rich Algae, Mineral Nutrition

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male trained cyclist.
  • Cycling for the purpose of exercise training (i.e. not cycling for transport) at least 100km per week for the last 6 months
  • VȮ2peak that is greater than 50 ml˙kg˙ml-1

Exclusion Criteria:

  • Any muscle disorder
  • Serious medical co-morbidities
  • Thyroid dysfunction or specific allergies
  • Contraindications to dependent variables
  • Currently participation in another research study
  • Currently not talking other nutrition supplements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Mineral Rich Algae with orange flavoring

    Water with orange flavoring

    Arm Description

    Participants will consume the Aquamin Soluble (Mineral Rich Algae) equivalent of 1000mg Calcium in 250 ml of orange flavoured water.

    Participants will consume a placebo of maltodextrin in 250 ml of orange flavoured water (40mg Calcium).

    Outcomes

    Primary Outcome Measures

    Blood lactate concentration accumulation (measured using a Lactate Pro2 Portable Analyzer; Arkray, Tokyo, Japan) to repeated Wingate anaerobic exhaustive exercise performed on a Lode Excalibur cycle ergometer (Lode B.V., Groningen, DE).
    Pre, during and post repeated Wingate anaerobic exercise performance test (three Wingates separated by 3 minutes recovery) blood lactate accumulation (mmol/L) will be measured by capillary sampling and lactate recovery (mmol/L) will be measured for a subsequent 20 minutes. The primary outcome measure will be any difference in blood lactate response between the interventions after 7 days of supplementation with either Aqumin or a placebo (see arms and interventions section).

    Secondary Outcome Measures

    Exercise performance via Wingate anaerobic exercise performance test for maximal power output (Watts) performed on a Lode Excalibur cycle ergometer (Lode B.V., Groningen, DE).
    A repeated Wingate anaerobic exercise performance test (three Wingates separated by 3 minutes recovery) will be used to assessed pre and post intervention maximal lower-body power output (measured in absolute Watts (W) and relative power output (W/kg)) and fatigued power output (measured in absolute Watts (W) and relative power output (W/kg)). The secondary outcome measure will be any difference power output in response to 7 days of supplementation with either Aqumin or a placebo (see arms and interventions section).

    Full Information

    First Posted
    May 28, 2019
    Last Updated
    June 7, 2019
    Sponsor
    University College Dublin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03980678
    Brief Title
    Lithothamnion Species on Blood Lactate During Exhaustive Exercise in Trained Cyclists
    Acronym
    AAPt
    Official Title
    Effect of Red Algae Lithothamnion on Blood Lactate Response During Exhaustive Exercise in Trained Cyclists: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    February 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College Dublin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Deep ocean mineral water has been shown to improve exercise phenotypes in human and animal models. However, there is yet to be an investigation of Algae species such as Lithothamnion that absorb and concentrate these minerals. Therefore, the AAP trial will investigate the effect of water soluble Lithothamnion species on exhaustive exercise-induced blood lactate accumulation, recovery and power output in trained cyclists.
    Detailed Description
    The potential for naturally derived combinations of marine minerals to improve exercise performance is growing throughout the scientific literature and has physiologically plausible mechanisms, likely through the diverse molecular and enzymatic actions of individual (or combinations of) minerals (such as Calcium and Magnesium). Despite the biological potential, there is little consciences whether mineral supplementation can improving markers of, and exercise performance. One recent investigation of deep ocean mineral water (high in marine minerals) showed that when consumed prior to exercise, blood lactate response improved with hyperthermal running and is supported in animal models - however, this is not supported elsewhere in humans. Nonetheless, others have shown, in human models, that deep ocean mineral water may improve exercise recovery, aerobic exercise performance, improve lower leg power output and hydration status compared to either placebo or sports drink. Furthermore, animal models support these plausibilities with improved mitochondrial biogenesis, biomolecules of exercises performance, cardiovascular hemodynamics, inflammatory cytokine responses to exercise and overall exercise adaptation. As ocean minerals are absorbed by marine organisms, Algae species such as Lithothamnion have higher concentrations of the same ocean minerals but structured differently at the nano scale and thus may have the potential to be more effective at improving exercise phenotypes. Therefore, the proposed exploratory RCT will investigate the effects of water soluble Lithothamnion species on exhaustive exercise-induced lactate accumulation, recovery and power output in trained cyclists, compared to a placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exercise-Induced Lactic Acidemia, Lactate Blood Increase
    Keywords
    Mineral Rich Algae, Mineral Nutrition

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    One week (7 day) supplementation, followed by a 4 week washout, then crossover (another 7 day supplementation period).
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    All parties directly involved in recruitment, data collection and analysis will be blinded to the supplement identities until after the data analysis.
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mineral Rich Algae with orange flavoring
    Arm Type
    Active Comparator
    Arm Description
    Participants will consume the Aquamin Soluble (Mineral Rich Algae) equivalent of 1000mg Calcium in 250 ml of orange flavoured water.
    Arm Title
    Water with orange flavoring
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will consume a placebo of maltodextrin in 250 ml of orange flavoured water (40mg Calcium).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Mineral Rich Algae
    Other Intervention Name(s)
    Aquamin soluble
    Intervention Description
    Lithothamnion species is rich in calcium, magnesium (Mg) and 72 other trace elements absorbed from sea-water during the organisms life. Mineral-rich 'fronds' break off from the living organism, fall to the ocean floor and are harvested (AquaminF). The mineral extract in soluble form contains ~13.1% Calcium, ~1.04% Magnesium and measurable levels of 72 other trace minerals. Following or prior to a washout period (crossover intervention), participants will consume the Aquamin Soluble equivalent of 1000mg Calcium in 250 ml of orange flavored water for a 7 day loading period.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Orange flavoured water with maltodextrin as the placebo
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Following or prior to a washout period (crossover intervention), participants will consume 250 ml of orange flavoured water (containing 20mg of Calcium with maltodextrin) for a 7 day period.
    Primary Outcome Measure Information:
    Title
    Blood lactate concentration accumulation (measured using a Lactate Pro2 Portable Analyzer; Arkray, Tokyo, Japan) to repeated Wingate anaerobic exhaustive exercise performed on a Lode Excalibur cycle ergometer (Lode B.V., Groningen, DE).
    Description
    Pre, during and post repeated Wingate anaerobic exercise performance test (three Wingates separated by 3 minutes recovery) blood lactate accumulation (mmol/L) will be measured by capillary sampling and lactate recovery (mmol/L) will be measured for a subsequent 20 minutes. The primary outcome measure will be any difference in blood lactate response between the interventions after 7 days of supplementation with either Aqumin or a placebo (see arms and interventions section).
    Time Frame
    40 minute exercise protocol
    Secondary Outcome Measure Information:
    Title
    Exercise performance via Wingate anaerobic exercise performance test for maximal power output (Watts) performed on a Lode Excalibur cycle ergometer (Lode B.V., Groningen, DE).
    Description
    A repeated Wingate anaerobic exercise performance test (three Wingates separated by 3 minutes recovery) will be used to assessed pre and post intervention maximal lower-body power output (measured in absolute Watts (W) and relative power output (W/kg)) and fatigued power output (measured in absolute Watts (W) and relative power output (W/kg)). The secondary outcome measure will be any difference power output in response to 7 days of supplementation with either Aqumin or a placebo (see arms and interventions section).
    Time Frame
    40 minute exercise protocol.

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male trained cyclist. Cycling for the purpose of exercise training (i.e. not cycling for transport) at least 100km per week for the last 6 months VȮ2peak that is greater than 50 ml˙kg˙ml-1 Exclusion Criteria: Any muscle disorder Serious medical co-morbidities Thyroid dysfunction or specific allergies Contraindications to dependent variables Currently participation in another research study Currently not talking other nutrition supplements
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shane M Heffernan, PhD
    Phone
    +353 (0)1 716 3256
    Ext
    3256
    Email
    shane.heffernan@ucd.ie
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katy Horner, PhD
    Phone
    +353 (0)1 716 3439
    Ext
    3439
    Email
    katy.horner@ucd.ie
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shane M Heffernan, PhD
    Organizational Affiliation
    University College Dublin
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Katy Horner, PhD
    Organizational Affiliation
    University College Dublin
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    All data and information will be presented in the peer reviewed manuscript.
    IPD Sharing Time Frame
    At the time of peer review publication.
    IPD Sharing Access Criteria
    Peer review publication.
    Citations:
    PubMed Identifier
    29472745
    Citation
    Perez-Turpin JA, Trottini M, Chinchilla-Mira JJ, Cyganik W. Effects of seawater ingestion on lactate response to exercise in runners. Biol Sport. 2017 Dec;34(4):407-412. doi: 10.5114/biolsport.2017.70733. Epub 2017 Oct 10.
    Results Reference
    background
    PubMed Identifier
    27284418
    Citation
    Fan H, Tan Z, Hua Y, Huang X, Gao Y, Wu Y, Liu B, Zhou Y. Deep sea water improves exercise and inhibits oxidative stress in a physical fatigue mouse model. Biomed Rep. 2016 Jun;4(6):751-757. doi: 10.3892/br.2016.651. Epub 2016 Apr 13.
    Results Reference
    background
    PubMed Identifier
    29311955
    Citation
    Wei CY, Chen CY, Liao YH, Tsai YS, Huang CY, Chaunchaiyakul R, Higgins MF, Kuo CH. Deep Ocean Mineral Supplementation Enhances the Cerebral Hemodynamic Response during Exercise and Decreases Inflammation Postexercise in Men at Two Age Levels. Front Physiol. 2017 Dec 12;8:1016. doi: 10.3389/fphys.2017.01016. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    23402436
    Citation
    Hou CW, Tsai YS, Jean WH, Chen CY, Ivy JL, Huang CY, Kuo CH. Deep ocean mineral water accelerates recovery from physical fatigue. J Int Soc Sports Nutr. 2013 Feb 12;10(1):7. doi: 10.1186/1550-2783-10-7.
    Results Reference
    background
    PubMed Identifier
    25002835
    Citation
    Stasiule L, Capkauskiene S, Vizbaraite D, Stasiulis A. Deep mineral water accelerates recovery after dehydrating aerobic exercise: a randomized, double-blind, placebo-controlled crossover study. J Int Soc Sports Nutr. 2014 Jun 26;11:34. doi: 10.1186/1550-2783-11-34. eCollection 2014.
    Results Reference
    background
    PubMed Identifier
    27087798
    Citation
    Keen DA, Constantopoulos E, Konhilas JP. The impact of post-exercise hydration with deep-ocean mineral water on rehydration and exercise performance. J Int Soc Sports Nutr. 2016 Apr 16;13:17. doi: 10.1186/s12970-016-0129-8. eCollection 2016.
    Results Reference
    background
    PubMed Identifier
    27434863
    Citation
    Ha BG, Moon DS, Kim HJ, Shon YH. Magnesium and calcium-enriched deep-sea water promotes mitochondrial biogenesis by AMPK-activated signals pathway in 3T3-L1 preadipocytes. Biomed Pharmacother. 2016 Oct;83:477-484. doi: 10.1016/j.biopha.2016.07.009. Epub 2016 Jul 18.
    Results Reference
    background
    PubMed Identifier
    18175939
    Citation
    Katsuda S, Yasukawa T, Nakagawa K, Miyake M, Yamasaki M, Katahira K, Mohri M, Shimizu T, Hazama A. Deep-sea water improves cardiovascular hemodynamics in Kurosawa and Kusanagi-Hypercholesterolemic (KHC) rabbits. Biol Pharm Bull. 2008 Jan;31(1):38-44. doi: 10.1248/bpb.31.38.
    Results Reference
    background
    PubMed Identifier
    30323766
    Citation
    Saovieng S, Wu J, Huang CY, Kao CL, Higgins MF, Chuanchaiyakul R, Kuo CH. Deep Ocean Minerals Minimize Eccentric Exercise-Induced Inflammatory Response of Rat Skeletal Muscle. Front Physiol. 2018 Sep 28;9:1351. doi: 10.3389/fphys.2018.01351. eCollection 2018.
    Results Reference
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    Citation
    Wang, S.-T., Hwang, D.-F., Chen, R.-H., & Chen, Y.-C. (2009). Effect of deep sea water on the exercise-induced fatigue of rats. Journal of Food and Drug Analysis, 17(2), 133-141.
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    Citation
    Heffernan SM, Horner K, De Vito G, Conway GE. The Role of Mineral and Trace Element Supplementation in Exercise and Athletic Performance: A Systematic Review. Nutrients. 2019 Mar 24;11(3):696. doi: 10.3390/nu11030696.
    Results Reference
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    Lithothamnion Species on Blood Lactate During Exhaustive Exercise in Trained Cyclists

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