HypoglycemiaNCT02909881
Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes
A study testing Use of PhytoSpherix at 0 g/min, Use of PhytoSpherix at 1 g/min and Use of PhytoSpherix at 1.5 g/min in people with Hypoglycemia, run by University of Western Ontario, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Use of PhytoSpherix at 0 g/min, Use of PhytoSpherix at 1 g/min and Use of PhytoSpherix at 1.5 g/min
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male endurance trained athletes with >2 y cycling experience; about 2 h/day
Who cannot join
- Unhealthy athletes, smokers
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Nutrition Research Laboratory, Western University
London, Ontario, N6A 3K7
About this study
Official title: Dose Response Oxidation of a Sweet-corn Derived Polysaccharide (PhytoSpherix) During Exercise in Endurance Trained Athletes
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.
Read the 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.
- Conditions
- Hypoglycemia
- Being tested
- 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
- Keywords
- polysaccharide, oxidation, endurance exercise
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of PhytoSpherix at 0 g/minDietary supplement
PhytoSpherix (Sweet-corn derived sugar) will be fed at 0 g/min during a 150 min cycling exercise
Use of PhytoSpherix at 1 g/minDietary supplement
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/minDietary supplement
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/minDietary supplement
PhytoSpherix (Sweet-corn derived sugar) will be fed at 2 g/min during a 150 min cycling exercise
Cycling exerciseBehavioural
Male endurance athletes will complete a cycling exercise for 150 min at 50% of their respective maximum wattage
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Use of PhytoSpherix at 0 g/min; Dietary Supplement: Use of PhytoSpherix at 1 g/min; Dietary Supplement: Use of PhytoSpherix at 1.5 g/min; Dietary Supplement: Use of PhytoSpherix at 2 g/min; Behavioral: Cycling exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 10 min before and 10 min after the 150 min exercise session
Secondary outcomes (5)
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
Measured: 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
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
Measured: 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
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.
Measured: At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
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.
Measured: 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
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).
Measured: At 30, 60, 90, 120 and 150 min from the beginning of the exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Mirexus Biotechnologies Inc
- Responsible party
- Principal investigator, Peter Lemon, University of Western Ontario, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909881
- Sponsor's protocol ID
- 10014597
- Status last verified
- Sep 2016
- First submitted
- 10 Sep 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34255078
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Oxidation of a Sweet-corn Derived Polysaccharide (PhytoSpherix) During Exercise in Endurance Trained Athletes
- ClinicalTrials.gov ID
- NCT02909881
- Acronym / sponsor ID
- 10014597
- Conditions
- Hypoglycemia
- Keywords
- polysaccharide, oxidation, endurance exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Mirexus Biotechnologies Inc
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endurance trained male cyclists | Experimental | Dietary Supplement: Use of PhytoSpherix at 0 g/min, Dietary Supplement: Use of PhytoSpherix at 1 g/min, Dietary Supplement: Use of PhytoSpherix at 1.5 g/min, Dietary Supplement: Use of PhytoSpherix at 2 g/min, Behavioral: Cycling exercise8 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male endurance trained athletes with >2 y cycling experience; about 2 h/day
Key exclusion criteria (1 listed)
- Unhealthy athletes, smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of PhytoSpherix at 0 g/minPhytoSpherix (Sweet-corn derived sugar) will be fed at 0 g/min during a 150 min cycling exercise | Dietary supplement | Endurance trained male cyclists |
| Use of PhytoSpherix at 1 g/minPhytoSpherix (Sweet-corn derived sugar) will be fed at 1 g/min during a 150 min cycling exercise | Dietary supplement | Endurance trained male cyclists |
| Use of PhytoSpherix at 1.5 g/minPhytoSpherix (Sweet-corn derived sugar) will be fed at 1.5 g/min during a 150 min cycling exercise | Dietary supplement | Endurance trained male cyclists |
| Use of PhytoSpherix at 2 g/minPhytoSpherix (Sweet-corn derived sugar) will be fed at 2 g/min during a 150 min cycling exercise | Dietary supplement | Endurance trained male cyclists |
| Cycling exerciseMale endurance athletes will complete a cycling exercise for 150 min at 50% of their respective maximum wattage | Behavioural | Endurance trained male cyclists |
Primary outcome
Oxidation of PhytoSpherixat
Time frame: 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
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
Time frame: 10 min before and 10 min after the 150 min exercise session
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.
5 secondary outcomes
blood glucose concentration
Time frame: 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
blood lactate concentration
Time frame: 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
Respiratory exchange ratio
Time frame: At 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session
rate of perceived exertion
Time frame: 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
Time frame: At 30, 60, 90, 120 and 150 min from the beginning of the exercise session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Derived from this study: PubMed 34255078Bandegan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lemon, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of PhytoSpherix at 0 g/min, Use of PhytoSpherix at 1 g/min and Use of PhytoSpherix at 1.5 g/min in people with Hypoglycemia, run by University of Western Ontario, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Lemon, PhD (519 661 2111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidation of PhytoSpherixat (time frame: 0, 15, 30, 45, 60, 75, 90, 135, 150 min from the beginning of the exercise session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.