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Ergogenic effects of different continuous carbohydrate feedings on time to exhaustion in healthy individuals: A randomized, double-blind, placebo-controlled crossover trial

Not Applicable
Conditions
healthy volunteers
Registration Number
DRKS00030531
Lead Sponsor
Bayreuther Zentrum für SportwissenschaftUniversität Bayreuth
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
23
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

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.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
tpeak: Time until exhaustion (TTE) in minutes:seconds during constant load cycling at the LTP2 in comparison of trial arms.
Secondary Outcome Measures
NameTimeMethod
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