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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03980678
Other study ID # AAPtrial
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2019
Est. completion date February 2020

Study information

Verified date June 2019
Source University College Dublin
Contact Shane M Heffernan, PhD
Phone +353 (0)1 716 3256
Email shane.heffernan@ucd.ie
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date February 2020
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

- V?2peak 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 Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University College Dublin

References & Publications (11)

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. Epub 2016 Apr 13. — View 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. — View 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). pii: E696. doi: 10.3390/nu11030696. Review. — View 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. — View 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. — View 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. — View Citation

Pérez-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. — View 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. — View 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. — View 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.

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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). 40 minute exercise protocol.
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