Healthy volunteers Metabolism during intermittent fasting
Conditions
Interventions
Group 1: 16/8 Intermittent Fasting: During 16/8 intermittent fasting periods participants should fast for 16 consecutive hours. During that time only, the consumption of water is allowed. No diet drin
Sponsors
Division Exercise Physiology and Metabolism
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 > 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of ADF, 16/8 IF and 20/4 IF on BMI for eight consecutive weeks in comparison to the baseline measurement following the controlled run-in period at timepoint 0, at the end of phase 1 (week four) and at the end of phase 2 (week eight). This is followed by follow-up visits at Phase 3 (Week 12) and at Phase 4 (Week 37). | — |
Secondary
| Measure | Time frame |
|---|---|
| - BMI0-4: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on BMI from baseline (week zero) to the end of phase 1 (week four). - BMI4-8: Determine the efficacy of ADF, 16/8 IF, and 20/4 IF on BMI from the end of phase one (week four) to the end of phase two (week eight) - BMI8-12: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on BMI from the end of phase 2 (week eight) to the end of phase 3 (week twelve). - BMI12-37: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on BMI from the end of phase 3 (week twelve) to the end of phase 4 (week 37). - BMKG/0-4-8: Determine the efficacy of ADF, 16/8 IF, and 20/4 IF on BM for eight consecutive weeks compared to baseline measurements after the controlled induction phase at time 0, at the end of phase 1 (week four), and at the end of phase 2 (week eight) - BMKG/8-12-37: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on BMKG in consecutive weeks compared to the final measurement of phase 2 (week 8) at the end of phase 3 (week twelve) and phase 4 (week 37) - BIA0-4-8: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on the BMKG for eight consecutive weeks compared to the baseline measurement after the controlled phase-in at time 0, at the end of phase 1 (week four), and at the end of phase 2 (week eight) - BIA8-12-37: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on BIA in consecutive weeks compared to the final measurement of phase 2 (week 8) at the end of phase 3 (week twelve) and phase 4 (week 37) - WHR0-4-8: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on WHR for eight consecutive weeks compared to the baseline measurement after the controlled phase-in period at time 0, at the end of phase 1 (week four), and at the end of phase 2 (week eight) - WHR8-12-37: Determine the effectiveness of ADF, 16/8 IF, and 20/4 IF on WHR in consecutive weeks compared to the final measurement of phase 2 (week eight) at the end of phase 3 (week twelve) and phase 4 ( | — |
Countries
Germany
Contacts
Public ContactOthmar Moser
Division Exercise Physiology and Metabolism
Outcome results
None listed