DRKS00029003Completed未知
The Effects of Different Intermittent Fasting Interventions on Anthropometry, Metabolic Health and Functional Performance in Average Population: a randomised trial with a controlled run-in period - EDIF-1
Division Exercise Physiology and Metabolism0 sites32 target enrollmentStarted: June 13, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •Informed consent obtained
- •-Male or female aged 18–65 years (both inclusive)
- •-Body mass index > 20,0 kg/m2 (both inclusive)
- •-Body Mass specific oxygen uptake >20 ml/min/Kg-1 (VO2max)
- •-Normal glucose tolerance (measured via overnight fasting blood glucose levels)
Exclusion Criteria
- •1. Enrolment in other study
- •2. 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 the 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 excluded patients how have celiac 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.
- •3. Participant with a heart rate < 35 beats per minute (bpm) at screening (after resting for 5 min in supine position)
- •4. Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 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
- •5. Significant abnormal ECG at screening, as judged by the Investigator
- •6. Any chronic (metabolic) disorder or severe disease which, in the opinion of the Investigator might jeopardise participant’s safety or compliance with the protocol
- •7. 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
- •8. Potentially non-compliant or uncooperative during the trial, as judged by the Investigator
- •9. Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator
- •10. Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner).
Investigators
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