Exercise-Induced Lactic AcidemiaAAPtNCT03980678
Lithothamnion Species on Blood Lactate During Exhaustive Exercise in Trained Cyclists
A study testing Mineral Rich Algae in people with Exercise-Induced Lactic Acidemia and Lactate Blood Increase, run by University College Dublin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-Induced Lactic Acidemia, Lactate Blood Increase
- What is being tested?
- Mineral Rich Algae
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Feb 2020
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Red Algae Lithothamnion on Blood Lactate Response During Exhaustive Exercise in Trained Cyclists: A Randomized Control Trial
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.
Read the 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.
- Being tested
- Mineral Rich Algae, Orange flavoured water with maltodextrin as the placebo
- Keywords
- Mineral Rich Algae, Mineral Nutrition
- Medical subject headings
- Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mineral Rich AlgaeDietary supplement
Also called Aquamin soluble
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.
Orange flavoured water with maltodextrin as the placeboDietary supplement
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Mineral Rich Algae with orange flavoring | Active comparator | Participants will consume the Aquamin Soluble (Mineral Rich Algae) equivalent of 1000mg Calcium in 250 ml of orange flavoured water. Receives: Dietary Supplement: Mineral Rich Algae |
| Water with orange flavoring | Placebo comparator | Participants will consume a placebo of maltodextrin in 250 ml of orange flavoured water (40mg Calcium). Receives: Dietary Supplement: Orange flavoured water with maltodextrin as the placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 40 minute exercise protocol
Secondary outcomes (1)
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).
Measured: 40 minute exercise protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study startJun 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Exercise-Induced Lactic AcidemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One week (7 day) supplementation, followed by a 4 week washout, then crossover (another 7 day supplementation period).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shane M Heffernan, PhD, Principal investigator, University College DublinKaty Horner, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980678
- Sponsor's protocol ID
- AAPtrial
- Acronym
- AAPt
- Status last verified
- Jun 2019
- First submitted
- 28 May 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data and information will be presented in the peer reviewed manuscript.
Publications
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.
PubMed 29472745Fan 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.
PubMed 27284418Wei 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.
PubMed 29311955Hou 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.
PubMed 23402436Stasiule 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.
PubMed 25002835Keen 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.
PubMed 27087798Ha 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.
PubMed 27434863Katsuda 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.
PubMed 18175939Saovieng 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.
PubMed 30323766Wang, 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.
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.
PubMed 30909645
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Red Algae Lithothamnion on Blood Lactate Response During Exhaustive Exercise in Trained Cyclists: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03980678
- Acronym / sponsor ID
- AAPt / AAPtrial
- Keywords
- Mineral Rich Algae, Mineral Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 10 Jun 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One week (7 day) supplementation, followed by a 4 week washout, then crossover (another 7 day supplementation period).
| Arm | Type | Receives |
|---|---|---|
| Mineral Rich Algae with orange flavoring | Active comparator | Dietary Supplement: Mineral Rich AlgaeParticipants will consume the Aquamin Soluble (Mineral Rich Algae) equivalent of 1000mg Calcium in 250 ml of orange flavoured water. |
| Water with orange flavoring | Placebo comparator | Dietary Supplement: Orange flavoured water with maltodextrin as the placeboParticipants will consume a placebo of maltodextrin in 250 ml of orange flavoured water (40mg Calcium). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Any muscle disorder
- Serious medical co-morbidities
- Thyroid dysfunction or specific allergies
- Contraindications to dependent variables
- Currently participation in another research study
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 |
|---|---|---|
| Mineral Rich AlgaeAlso: Aquamin solubleLithothamnion 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. | Dietary supplement | Mineral Rich Algae with orange flavoring |
| Orange flavoured water with maltodextrin as the placeboAlso: PlaceboFollowing 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. | Dietary supplement | Water with orange flavoring |
Primary outcome
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).
Time frame: 40 minute exercise protocol
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).
1 secondary outcome
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).
Time frame: 40 minute exercise protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Background: PubMed 29472745Perez-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.
- Background: PubMed 27284418Fan 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.
- Background: PubMed 29311955Wei 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.
- Background: PubMed 23402436Hou 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.
- Background: PubMed 25002835Stasiule 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.
- Background: PubMed 27087798Keen 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.
- Background: PubMed 27434863Ha 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.
- Background: PubMed 18175939Katsuda 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.
- Background: PubMed 30323766Saovieng 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.
- BackgroundWang, 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.
- Background: PubMed 30909645Heffernan 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.
- Individual participant dataSharing planned: Yes. All data and information will be presented in the peer reviewed manuscript.
Related trials for Exercise-Induced Lactic Acidemia
Recruiting
Microbiome Sampling During Endurance Exercise
Healthy, Exercise-Induced Lactic Acidemia
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.
Shane M Heffernan, PhD principal investigator
University College Dublin
Katy Horner, PhD principal investigator
University College Dublin
Questions about this trial
What is this clinical trial studying?
A study testing Mineral Rich Algae in people with Exercise-Induced Lactic Acidemia and Lactate Blood Increase, run by University College Dublin.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shane M Heffernan, PhD (+353 (0)1 716 3256 ext. 3256, shane.heffernan@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 40 minute exercise protocol). 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 NCT03980678, which also lists 11 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 10 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.