A Randomised Counter-balanced Intervention Study in Endurance AthletesNCT05519800
The Metabolic Effects of Ultra-endurance Exercise and Training Under Low or High Glycaemic Index-carbohydrate Diets.
A study testing Isomaltulose and Maltodextrin in people with A Randomised Counter-balanced Intervention Study in Endurance Athletes, run by Swansea University at 1 site in United Kingdom.
Trial summary
A randomised counter-balanced intervention study in endurance athletes Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- A Randomised Counter-balanced Intervention Study in Endurance Athletes
- What is being tested?
- Isomaltulose and Maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 22 Nov 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent obtained
- Male or female aged 18-65 years (both inclusive)
- Otherwise healthy (as judged by premedical questionnaire) and participating in regular training (volume in training >10 h training per week) and participating in endurance events and/or VO2max > 55 ml.kg-1.min-1.
Who cannot join
- Receipt of any investigational medicinal product within 1 month prior to screening in this trial
- Haemoglobin <8.0 mmol/L (male) or <7.0 mmol/L (female).
- Systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone and non-routine vitamins and herbal products. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
- Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences their metabolism (e.g. statin) or cardio- respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not exclude patients how have coeliac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten- free diet.
- Known cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time
- Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement on a second screening Visit shows values within the range, the participant can be included in the trial). This exclusion criterion also pertains to participants being on anti-hypertensives.
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- History of clinically significant abnormal ECG issues, as judged by the Investigator.
- Severe retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
- Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise participant's safety or compliance with the protocol.
- History of allergies and/or intolerances to drugs or foods or a history of severe anaphylactic reaction e.g. fructose intolerance.
- Significant history of alcoholism or drug/chemical abuse as per Investigator's judgement or a positive result in the urine drug/alcohol screen at the screening Visit.
- Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day).
- Not able or willing to refrain from smoking or use of nicotine substitute products during the monitoring period.
- Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial.
- Participating in any other research trial which may interfere with the current study.
- Potentially non-compliant or uncooperative during the trial, as judged by the Investigator.
- Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator.
- Any known history of diabetes mellitus, or the use of any anti- hyperglycaemic drug or insulin to treat diabetes and related conditions.
Trial locations and contacts
1 site in 1 country.
About this study
A randomised counter-balanced intervention study in endurance athletes
Read the detailed description
To characterise glycaemic, dietary, physiological, and metabolic responses around intense endurance exercise and training in ultra-endurance athletes.
Primary objective
- Detail the proportion of time spent in glycaemic ranges over a prolonged period of training under the influence of different GI diets in Ultra-endurance athletes.
Secondary Objectives
- Characterise physiological responses to differing GI diets during a period of extensive endurance exercise through hormonal markers.
- Observe the influence of differing GI diets on the impact of endurance performance and short term recovery from endurance exercise, detailing the influence of different GI carbohydrate on the restoration of performance output.
- Observe the perception of wellness and gut discomfort using either high or low GI diets supplemented with high or low GI carbohydrates.
- Being tested
- Isomaltulose, Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsomaltuloseDietary supplement
Also called Palatinose
Diet will be supplemented with a beverage containing Isomaltulose as a carbohydrate source.
MaltodextrinDietary supplement
Diet will be supplemented using a beverage containing Maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| High Glycaemic Index | Active comparator | A diet comprising of High Glycaemic Carbohydrate. Supplemented with a maltodextrin containing beverage. Receives: Dietary Supplement: Maltodextrin |
| Low Glycaemic Index | Experimental | A diet comprising of Low Glycaemic Carbohydrate. Supplemented with an Isomaltulose containing beverage. Receives: Dietary Supplement: Isomaltulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial Glucose Percentage Coefficient of Variation.
A metric which is related to the daily variation of Interstitial Glucose concentration relative to mean concentration.
Measured: 24 months
Secondary outcomes (7)
Mean blood and interstitial glucose concentration.
A measure of mean concentration of glucose in both blood and interstitial fluid.
Measured: 24 Months
% Time Spent in Range
A characterisation of Interstitial Glucose Concentration in defined ranges.Hyperglycaemia (+7 mmol.L-1), Euglycaemia (4.0-7 mmol.L-1), Hypoglycaemia (<3.9 mmol.L-1).
Measured: 24 Months
Performance changes
Physical performance as measured by time to task failure following re-feed protocol of either high or low glycaemic carbohydrates
Measured: 24 Months
Cardio vascular indicators during exercise
Observing potential changes in the following during repeated exercise trial. Heart rate Vo2 Fuel Oxidization Carbohydrate:Fat oxidization
Measured: 24 Months
Metabolic and hormonal change in response to re-feed of high or low glycaemic carbohydrate.
Observing any potential adaptation or impact on metabolic or hormones. Assessed through the following Insulin response Intestinal fatty-acid binding protein (iFABP) Triglycerides Glycerol Free Fatty Acids Liver stress enzymes (Alkaline Phosphatase, Aspartate aminotransferase, Alanine transaminase, Gamma-glutamyl transferase \& total bilirubin) Cardiac and Muscle enzymes (Heart-type fatty acid binding protein, Cardiac troponin, Creatine kinase \& Myoglobin) Ketones
Measured: 24 Months
Gut distress
Record of potential gut distress via Gastrointestinal Symptom Rating Scale (GSRS).
Measured: 24 Months
3. Comparison of lifestyle and wellness when on either high or low Glycaemic diet.
Observing impact or changes on daily background activity and sleep.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Oct 2022
- Primary completion1 Jun 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A Randomised Counter-balanced Intervention Study in Endurance AthletesStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- randomised counter-balanced
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Beneo GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519800
- Sponsor's protocol ID
- U1111-1281-5048
- Status last verified
- Nov 2023
- First submitted
- 15 Aug 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of Ultra-endurance Exercise and Training Under Low or High Glycaemic Index-carbohydrate Diets.
- ClinicalTrials.gov ID
- NCT05519800
- Acronym / sponsor ID
- U1111-1281-5048
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Beneo GmbH
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- 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.
A randomised counter-balanced intervention study in endurance athletes
Detailed description
To characterise glycaemic, dietary, physiological, and metabolic responses around intense endurance exercise and training in ultra-endurance athletes.
Primary objective
- Detail the proportion of time spent in glycaemic ranges over a prolonged period of training under the influence of different GI diets in Ultra-endurance athletes.
Secondary Objectives
- Characterise physiological responses to differing GI diets during a period of extensive endurance exercise through hormonal markers.
- Observe the influence of differing GI diets on the impact of endurance performance and short term recovery from endurance exercise, detailing the influence of different GI carbohydrate on the restoration of performance output.
- Observe the perception of wellness and gut discomfort using either high or low GI diets supplemented with high or low GI carbohydrates.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomised counter-balanced
| Arm | Type | Receives |
|---|---|---|
| High Glycaemic Index | Active comparator | Dietary Supplement: MaltodextrinA diet comprising of High Glycaemic Carbohydrate. Supplemented with a maltodextrin containing beverage. |
| Low Glycaemic Index | Experimental | Dietary Supplement: IsomaltuloseA diet comprising of Low Glycaemic Carbohydrate. Supplemented with an Isomaltulose containing beverage. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent obtained
- Male or female aged 18-65 years (both inclusive)
- Otherwise healthy (as judged by premedical questionnaire) and participating in regular training (volume in training >10 h training per week) and participating in endurance events and/or VO2max > 55 ml.kg-1.min-1.
Key exclusion criteria (18 listed)
- Receipt of any investigational medicinal product within 1 month prior to screening in this trial
- Haemoglobin <8.0 mmol/L (male) or <7.0 mmol/L (female).
- Systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone and non-routine vitamins and herbal products. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
- Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences their metabolism (e.g. statin) or cardio- respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not exclude patients how have coeliac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten- free diet.
- Known cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time
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 |
|---|---|---|
| IsomaltuloseAlso: PalatinoseDiet will be supplemented with a beverage containing Isomaltulose as a carbohydrate source. | Dietary supplement | Low Glycaemic Index |
| MaltodextrinDiet will be supplemented using a beverage containing Maltodextrin. | Dietary supplement | High Glycaemic Index |
Primary outcome
Interstitial Glucose Percentage Coefficient of Variation.
Time frame: 24 months
A metric which is related to the daily variation of Interstitial Glucose concentration relative to mean concentration.
7 secondary outcomes
Mean blood and interstitial glucose concentration.
Time frame: 24 Months
% Time Spent in Range
Time frame: 24 Months
Performance changes
Time frame: 24 Months
Cardio vascular indicators during exercise
Time frame: 24 Months
Metabolic and hormonal change in response to re-feed of high or low glycaemic carbohydrate.
Time frame: 24 Months
Gut distress
Time frame: 24 Months
3. Comparison of lifestyle and wellness when on either high or low Glycaemic diet.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomaltulose and Maltodextrin in people with A Randomised Counter-balanced Intervention Study in Endurance Athletes, run by Swansea University at 1 site in United Kingdom.
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 3 inclusion and 18 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: finished, as of the sponsor's last update on 24 Nov 2023. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interstitial Glucose Percentage Coefficient of Variation. (time frame: 24 months). 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 Nov 2023.