Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes

Hypoglycemia Clinical Trial

Official title:

Dose Response Oxidation of a Sweet-corn Derived Polysaccharide (PhytoSpherix) During Exercise in Endurance Trained Athletes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02909881
• Other study ID #: 10014597
• Status: Not yet recruiting
• Phase: N/A
• First received: September 10, 2016
• Last updated: September 21, 2016
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2016
• Source: University of Western Ontario, Canada
• Contact: Peter Lemon, PhD
• Phone: 519 661 2111
• Email: plemon[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

Carbohydrate (CHO) is one of the main substrate oxidized during moderate-to-high intensity, endurance-type exercise. It's been shown that CHO feeding during exercise enhances endurance performance and capacity, attributed mainly to the facilitation of greater rates of exogenous CHO oxidation, prevention of hypoglycaemia and sparing of muscle glycogen. Previous studies based on supplementation of glucose during 180 min. of cycling exercise have reported a maximal rate of exogenous CHO oxidation to be about 1 g/min. Other studies have shown that CHO oxidation rates can reach peak values of about 1.3 g/min when a combination of fructose and glucose is ingested at a rate of 1.8 g/min. The limitation in uptake and oxidation of a single CHO source is attributed to its intestinal transporter saturation such that when multiple CHO source is used the uptake and oxidation rate is increased to a greater extent. Currently there is no information regarding Phx uptake or oxidation rate as a CHO source during exercise. Also, it is important to investigate whether Phx as a CHO sport drink can increase performance by sparing muscle and liver glycogen during exercise. Therefore, the objective of this experiment is to measure dose response of Phx oxidation rate during prolonged cycling exercise and its effect on muscle and liver glycogen levels.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy male endurance trained athletes with >2 y cycling experience; about 2 h/day

Exclusion Criteria:

• Unhealthy athletes, smokers

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Dietary Supplement:
• Use of PhytoSpherix at 0 g/min
PhytoSpherix (Sweet-corn derived sugar) will be fed at 0 g/min during a 150 min cycling exercise
• Use of PhytoSpherix at 1 g/min
PhytoSpherix (Sweet-corn derived sugar) will be fed at 1 g/min during a 150 min cycling exercise
• Use of PhytoSpherix at 1.5 g/min
PhytoSpherix (Sweet-corn derived sugar) will be fed at 1.5 g/min during a 150 min cycling exercise
• Use of PhytoSpherix at 2 g/min
PhytoSpherix (Sweet-corn derived sugar) will be fed at 2 g/min during a 150 min cycling exercise

Behavioral:
• Cycling exercise
Male endurance athletes will complete a cycling exercise for 150 min at 50% of their respective maximum wattage

Locations

Country	Name	City	State
Canada	Exercise Nutrition Research Laboratory, Western University	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Mirexus Biotechnologies Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	blood glucose concentration	Changes in blood glucose will be measured at 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session. A blood drop by finger prick approach starting at time 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session under sterile practice will be used to determine blood glucose concentrations	0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session	No
Secondary	blood lactate concentration	Changes in blood lactate will be measured at 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session. A blood drop by finger prick approach starting at time 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session under sterile practice will be used to determine blood lactate concentrations	0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session	No
Secondary	Respiratory exchange ratio	Respiratory exchange ratio will be measured at 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session for periods of 4 min by using an online automated gas-analysis system.	At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session	No
Secondary	rate of perceived exertion	rate of perceived exertion (RPE) for whole body and legs will be measured at 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session on a scale from 6 to 20, using the Borg category scale.	At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session	No
Secondary	questionnaire to rate possible gastrointestinal (GI) problems	every athlete will be asked at 30, 60, 90, 120 and 150 min from the beginning of the exercise session to fill in a questionnaire to rate possible gastrointestinal (GI) problems including stomach problems, GI cramping, bloated feeling, diarrhea, nausea, dizziness, headache, belching, vomiting, and urge to urinate and defecate. While cyclists are on the bike and continue their exercise, each question will be answered by simply ticking a box on the questionnaire that corresponds to the severity of the GI problem addressed. The items will be scored on a 10-point scale (1 not at all, 10 very, very much).	At 30, 60, 90, 120 and 150 min from the beginning of the exercise session	No