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

June 7, 2019 updated by: University College Dublin

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mineral Rich Algae with orange flavoring
Participants will consume the Aquamin Soluble (Mineral Rich Algae) equivalent of 1000mg Calcium in 250 ml of orange flavoured water.
Dietary supplement: Mineral Rich Algae
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.
Other Names:
  • Aquamin soluble
Placebo Comparator: Water with orange flavoring
Participants will consume a placebo of maltodextrin in 250 ml of orange flavoured water (40mg Calcium).
Dietary supplement: Orange flavoured water with maltodextrin as the 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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
40 minute exercise protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
40 minute exercise protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Investigators

  • Principal Investigator: Katy Horner, PhD, University College Dublin
  • Principal Investigator: Shane M Heffernan, PhD, University College Dublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAPtrial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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