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

Primary Purpose

Hypoglycemia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Use of PhytoSpherix at 0 g/min
Use of PhytoSpherix at 1 g/min
Use of PhytoSpherix at 1.5 g/min
Use of PhytoSpherix at 2 g/min
Cycling exercise
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoglycemia focused on measuring polysaccharide, oxidation, endurance exercise

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Unhealthy athletes, smokers

Sites / Locations

  • Exercise Nutrition Research Laboratory, Western University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endurance trained male cyclists

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
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
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.
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.
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).

Full Information

First Posted
September 10, 2016
Last Updated
September 21, 2016
Sponsor
University of Western Ontario, Canada
Collaborators
Mirexus Biotechnologies Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02909881
Brief Title
Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes
Official Title
Dose Response Oxidation of a Sweet-corn Derived Polysaccharide (PhytoSpherix) During Exercise in Endurance Trained Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Mirexus Biotechnologies Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
polysaccharide, oxidation, endurance exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endurance trained male cyclists
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Use of PhytoSpherix at 0 g/min
Intervention Description
PhytoSpherix (Sweet-corn derived sugar) will be fed at 0 g/min during a 150 min cycling exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Use of PhytoSpherix at 1 g/min
Intervention Description
PhytoSpherix (Sweet-corn derived sugar) will be fed at 1 g/min during a 150 min cycling exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Use of PhytoSpherix at 1.5 g/min
Intervention Description
PhytoSpherix (Sweet-corn derived sugar) will be fed at 1.5 g/min during a 150 min cycling exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Use of PhytoSpherix at 2 g/min
Intervention Description
PhytoSpherix (Sweet-corn derived sugar) will be fed at 2 g/min during a 150 min cycling exercise
Intervention Type
Behavioral
Intervention Name(s)
Cycling exercise
Intervention Description
Male endurance athletes will complete a cycling exercise for 150 min at 50% of their respective maximum wattage
Primary Outcome Measure Information:
Title
Oxidation of PhytoSpherixat
Description
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
Time Frame
0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Title
Noninvasive ultrasound measure of glycogen in Vastus lateralis, rectus femoris and liver
Description
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.
Time Frame
10 min before and 10 min after the 150 min exercise session
Secondary Outcome Measure Information:
Title
blood glucose concentration
Description
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
Time Frame
0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Title
blood lactate concentration
Description
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
Time Frame
0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Title
Respiratory exchange ratio
Description
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.
Time Frame
At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Title
rate of perceived exertion
Description
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.
Time Frame
At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Title
questionnaire to rate possible gastrointestinal (GI) problems
Description
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).
Time Frame
At 30, 60, 90, 120 and 150 min from the beginning of the exercise session

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male endurance trained athletes with >2 y cycling experience; about 2 h/day Exclusion Criteria: Unhealthy athletes, smokers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Lemon, PhD
Phone
519 661 2111
Ext
88139
Email
plemon@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Arash Bandegan, PhD
Phone
519 661 2111
Ext
88139
Email
abandega@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lemon, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise Nutrition Research Laboratory, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34255078
Citation
Bandegan A, Huang L, Longstaffe FJ, Lemon PW. Dose-Response Oxidation of Ingested Phytoglycogen during Exercise in Endurance-Trained Men. J Nutr. 2021 Oct 1;151(10):2942-2948. doi: 10.1093/jn/nxab219.
Results Reference
derived

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

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