NCT03980678

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 10, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

May 28, 2019

Last Update Submit

June 7, 2019

Conditions

Exercise-Induced Lactic AcidemiaLactate Blood Increase

Keywords

Mineral Rich AlgaeMineral Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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).

    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).

    40 minute exercise protocol.

Study Arms (2)

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.

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).

Dietary Supplement: Orange flavoured water with maltodextrin as the placebo

Interventions

Mineral Rich AlgaeDIETARY_SUPPLEMENT

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.

Also known as: Aquamin soluble
Mineral Rich Algae with orange flavoring
Orange flavoured water with maltodextrin as the placeboDIETARY_SUPPLEMENT

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.

Also known as: Placebo
Water with orange flavoring

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 29472745BACKGROUND

  • 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.

    PMID: 27284418BACKGROUND

  • 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.

    PMID: 29311955BACKGROUND

  • 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.

    PMID: 23402436BACKGROUND

  • 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.

    PMID: 25002835BACKGROUND

  • 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.

    PMID: 27087798BACKGROUND

  • 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.

    PMID: 27434863BACKGROUND

  • 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.

    PMID: 18175939BACKGROUND

  • 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.

    PMID: 30323766BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 30909645BACKGROUND

MeSH Terms

Conditions

Hyperlactatemia

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shane M Heffernan, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

  • Katy Horner, PhD

    University College Dublin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shane M Heffernan, PhD

CONTACT

+353 (0)1 716 3256shane.heffernan@ucd.ie

Katy Horner, PhD

CONTACT

+353 (0)1 716 3439katy.horner@ucd.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All parties directly involved in recruitment, data collection and analysis will be blinded to the supplement identities until after the data analysis.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: One week (7 day) supplementation, followed by a 4 week washout, then crossover (another 7 day supplementation period).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 10, 2019

Study Start

June 1, 2019

Primary Completion

September 1, 2019

Study Completion

February 1, 2020

Last Updated

June 10, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

All data and information will be presented in the peer reviewed manuscript.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
At the time of peer review publication.
Access Criteria
Peer review publication.