FatigueNCT02045342
The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
A study testing Carbohydrate drink in people with Fatigue, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Carbohydrate drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Dec 2015
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, 18 to 35 year old man or woman.
Who cannot join
- smoker
- pregnancy
- taking part in other research.
- followed a weight loss diet in the previous 6 months.
- history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
- neurological or psychiatric condition that may cause cognitive dysfunction.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Nutrition Research Laboratory, Western University
London, Ontario, N6A 3K7
Peter Lemon, PhD, 519 661 2111 ext. 88139, plemon@uwo.ca
Peter Lemon, PhD
About this study
This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.
- Conditions
- Fatigue
- Being tested
- Carbohydrate drink, Placebo
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate drinkOther
Ingest 500ml (1g/kg) prior to metabolic measures.
PlaceboOther
Ingest 500ml of placebo prior to metabolic measures.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate drink | Experimental | Ingest 500ml (1g/kg) prior to metabolic measures. Receives: Other: Carbohydrate drink; Other: Placebo |
| Placebo | Placebo comparator | Ingest 500ml of placebo prior to metabolic measures. Receives: Other: Carbohydrate drink; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Consumption
Measured: Four 10 minute measures throughout 90 min protocol (1 day).
Secondary outcomes (2)
Appetite ratings
Measured: Four appetite ratings throughout 90 min protocol (1 day).
Cognitive function
Measured: 2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045342
- Sponsor's protocol ID
- 104111
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2014
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Carbohydrate Drink on Cognitive Function and Exercise Performance
- ClinicalTrials.gov ID
- NCT02045342
- Acronym / sponsor ID
- 104111
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 24 Jan 2014 (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.
This study will investigate the effects of hydrothermally modified starch (SuperStarch) in adults. SuperStarch, originally developed as a drink for children with glycogen storage disease, is a slow digestible carbohydrate, maintaining blood sugar levels over extended periods. Therefore, it could be beneficial to exercise and mental performance, and could possibly have fat loss effects by increasing feelings of fullness. In this study, measures will be taken in 25 men to assess mental function, appetite, and metabolism to determine the processes involved in possible fat loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate drink | Experimental | Other: Carbohydrate drink, Other: PlaceboIngest 500ml (1g/kg) prior to metabolic measures. |
| Placebo | Placebo comparator | Other: Carbohydrate drink, Other: PlaceboIngest 500ml of placebo prior to metabolic measures. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, 18 to 35 year old man or woman.
Key exclusion criteria (6 listed)
- smoker
- pregnancy
- taking part in other research.
- followed a weight loss diet in the previous 6 months.
- history of gastrointestinal, endocrine, cardiovascular disease or diabetes.
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 |
|---|---|---|
| Carbohydrate drinkIngest 500ml (1g/kg) prior to metabolic measures. | Other | Carbohydrate drink, Placebo |
| PlaceboIngest 500ml of placebo prior to metabolic measures. | Other | Carbohydrate drink, Placebo |
Primary outcome
Oxygen Consumption
Time frame: Four 10 minute measures throughout 90 min protocol (1 day).
2 secondary outcomes
Appetite ratings
Time frame: Four appetite ratings throughout 90 min protocol (1 day).
Cognitive function
Time frame: 2 computerized tests (Stroop Test, Trail Making test) repeated 3 times throughout 90 min protocol (1 day).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate drink in people with Fatigue, 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 6 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 24 Jan 2014. 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. Some participants in this study may receive a placebo. 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?
Oxygen Consumption (time frame: Four 10 minute measures throughout 90 min protocol (1 day).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2014.