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
About this trial
This is an interventional treatment trial for Exercise-Induced Lactic Acidemia focused on measuring Mineral Rich Algae, Mineral Nutrition
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
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
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
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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
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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
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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
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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
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PubMed Identifier
27087798
Citation
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Results Reference
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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.
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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.
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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.
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Citation
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Citation
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Results Reference
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Lithothamnion Species on Blood Lactate During Exhaustive Exercise in Trained Cyclists
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