Brief Summary

PhytoSpherix (Phx) is an all-natural, edible polysaccharide extracted from sweet corn. This carbohydrate is the major muscle fuel for intense exercise and its stores are quite small such that one can run out of it during a single exercise bout. Therefore, Phx should provide significant exercise fuel if consumed during exercise. As a result its intake could enhance intense exercise performance by providing additional fuel. This experiment Will investigate the effects of 4 different dosages of Phx consumed throughout a prolonged exercise bout on carbohydrate and fat utilization as well as its oxidation rate and perception of effort during prolonged intense exercise in trained cyclists. Muscle and liver carbohydrate stores will be examined using a non-invasive ultrasound technique.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Sep 2016

Geographic Reach

1 country

1 active site

Status

unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

September 1, 2016

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2016

Completed

11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed

Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 10, 2016

Last Update Submit

September 21, 2016

Conditions

Hypoglycemia

Keywords

polysaccharideoxidationendurance exercise

Outcome Measures

Primary Outcomes (2)

Oxidation of PhytoSpherixat
Breath samples will be taken starting at 0, 15, 30, 45, 60, 75, 90, 135, up to 150 min from the beginning of the exercise session to measure change in oxidation of PhytoSpherix
0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Noninvasive ultrasound measure of glycogen in Vastus lateralis, rectus femoris and liver
Change in muscle and liver glycogen will be measured 10 min before and 10 min after exercise session. When muscle and liver glycogen content is high, the ultrasound image is hypoechoic (dark), and with glycogen depletion and water loss, the image is hyperchoic (brighter).Three ultrasound measurements at each site will be made by a trained technician using a 12 MHz linear transducer and a standard diagnostic high resolution GE LOGIQ-e ultrasound machine (GE Healthcare, Milwaukee, WI). After calculating statistics on the color bar to determine the general brightness settings of the machine, images will be pre-processed and segmented to isolate the muscle area under analysis using a center crop within the muscle section 25 mm from the top muscle sheath. Comparing these results will help better understand the effect of supplementation of Phx at different rates on any changes in glycogen stores of muscle and liver.
10 min before and 10 min after the 150 min exercise session

Secondary Outcomes (5)

blood glucose concentration
0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
blood lactate concentration
0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Respiratory exchange ratio
At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
rate of perceived exertion
At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
questionnaire to rate possible gastrointestinal (GI) problems
At 30, 60, 90, 120 and 150 min from the beginning of the exercise session

Study Arms (1)

Endurance trained male cyclists

EXPERIMENTAL

8 male endurance trained male cyclist will consume varying amounts (0, 1, 1.5 and 2 g/min) of PhytoSpherix (sweet-corn derived sugar) during a 150 min . cycling exercise

Dietary Supplement: Use of PhytoSpherix at 0 g/minDietary Supplement: Use of PhytoSpherix at 1 g/minDietary Supplement: Use of PhytoSpherix at 1.5 g/minDietary Supplement: Use of PhytoSpherix at 2 g/minBehavioral: Cycling exercise