healthy volunteers
Conditions
Interventions
Group 1: Carbohydrate supplementation (20 g/h/L) at rest and every 10 minutes during a constant load exercise on a cycle ergometer
Group 2: Carbohydrate supplementation (40 g/h/L) at rest and every 10
Sponsors
Bayreuther Zentrum für SportwissenschaftUniversität Bayreuth
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Informed consent obtained. Male or female aged 18–65 years (both inclusive). Body mass index 18.0–29.9 kg·m-2 (both inclusive). Body mass specific maximum oxygen uptake (V?O2max) >20 mL·min-1·kg-1.
Exclusion criteria
Exclusion criteria: Simultaneous enrolment in any other study. Known or suspected hypersensitivity to trial products or related products. Receipt of any investigational medicinal product within 1 week prior to screening in this trial. Suffering 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 influence the metabolism (e.g. statin) or cardio-respiratory system (e.g. asthma spray) as long as the therapy is stable and not adapted throughout the run of the trial. Furthermore, it does not excluded patients who have celiac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific diet, e.g. gluten-free. Heart rate <35 beats per minute after resting for 5 min in supine position at screening Blood pressure outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic after resting for 5 min in supine position at screening (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. Significant abnormal ECG at screening, as judged by the medical investigator. Any chronic (metabolic) disorder or severe disease which, in the opinion of the investigator, might jeopardize the participant’s safety or compliance with the protocol. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction Participant with mental incapacity or language barriers including adequate understanding or cooperation or who, in the opinion of their general practitioner or the investigator, should not participate in the trial Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator Females of childbearing potential who intend to become pregnant or are pregnant, or are not using adequate contraceptive methods (adequate contraceptive measures include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomized partner). This also includes females who are breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpeak: Time until exhaustion (TTE) in minutes:seconds during constant load cycling at the LTP2 in comparison of trial arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucosestart: Mean ± standard deviation and coefficient of variation of blood glucose levels (mg·dL-1) prior to the start of constant load cycling exercise at LTP 2 in comparison of trial arms. Glucoseduring: Mean ± standard deviation and coefficient of variation of blood glucose levels (mg·dL-1) during constant load cycling exercise at LTP2 in comparison of trial arms. Glucoseend: Mean ± standard deviation and coefficient of variation of blood glucose levels (mg·dL-1) at the end of constant load cycling exercise at LTP2 in comparison of trial arms. Glucose?: Change in blood glucose levels (?mg·dL-1) between Glucosestart and Glucoseend in comparison of trial arms. Lactatestart: Mean ± standard deviation and coefficient of variation of blood lactate levels (mmol·L-1) prior to the start of constant load cycling exercise at LTP 2 in comparison of trial arms. Lactateduring: Mean ± standard deviation and coefficient of variation of blood lactate levels (mmol·L-1) during constant load cycling exercise at LTP2 in comparison of trial arms. Lactateend: Mean ± standard deviation and coefficient of variation of blood lactate levels (mmol·L-1) at the end of constant load cycling exercise at LTP2 in comparison of trial arms. Lactatepeak: Peak ± standard deviation of blood lactate levels (mmol·L-1) in comparison of trial arms. Lactate?: Change in blood lactate levels (?mmol·L-1) between Lactatestart and Lactateend, and Lactatestart and Lactatepeak, respectively, in comparison of trial arms. Insulinstart: Mean ± standard deviation of insulin levels (IU) at rest before constant load cycling exercise at LTP2 in comparison of trial arms. Insulin+10: Mean ± standard deviation of insulin levels (IU) after 10 minutes during constant load cycling exercise at LTP2 in comparison of trial arms. Insulinend: Mean ± standard deviation of insulin levels (IU) after constant load cycling exercise at LTP2 in comparison of trial arms. Insulin?: Change in insulin | — |
Countries
Germany
Contacts
Public ContactJanis Schierbauer
Bayreuther Zentrum für SportwissenschaftUniversität Bayreuth
Outcome results
None listed