Monitoring health effects of intermittent fasting in obese adults
Longitudinal Monitoring During Different Intermittent Fasting Protocols in Obese Adults - a Randomized Clinical Trial
This study is testing whether two types of intermittent fasting can help obese adults improve their health compared to regular weight-loss counseling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT06323889 on ClinicalTrials.gov |
What this trial studies
This clinical intervention investigates the effects of two intermittent fasting protocols—modified alternate day fasting and time-restricted eating—compared to a control group receiving general weight-loss counseling. A total of 90 obese adults, aged 18-50 with a BMI between 30 and 40, will be randomized into three groups to assess the impact of these dietary strategies on health outcomes. The study aims to address the rising prevalence of obesity and its associated health risks by exploring alternative dietary approaches to weight management.
Who should consider this trial
Good fit: Ideal candidates for this study are obese adults aged 18-50 with a BMI between 30 and 40 who are non-smokers and have stable body weight.
Not a fit: Patients who regularly fast for more than 12 hours a day or have severe food allergies or dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies for weight loss and improved metabolic health in obese individuals.
How similar studies have performed: Previous studies have shown promising results with intermittent fasting approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18-50 years, both inclusive * Obese, BMI between 30 and 40 kg/m\^2 (obesity grade I or II), both inclusive * Non-smoker * Good knowledge of German or English language * Stable weight change (change \< +/- 3% current bodyweight) for 3 months prior to the study * HbA1c \< 6.5% without glucose lowering medication * LDL-cholesterol \< 4.6mmol/l without lipid lowering medication Exclusion Criteria: * Participants who have a fasting period of \> 12h per day on a regular basis and do not eat at least three main meals per day. * Current habitual use of dietary supplements (e.g., vitamins, minerals) and/or unwillingness to cease intake of dietary supplements. * Antibiotics intake during 3 months prior to the study due to possible interference with metabolic parameters * Food intolerances, allergies and sensitivities (severe food allergies) or dietary restrictions (e.g. vegan lifestyle) * Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study. * Diabetes * Known alcohol, substance or drug abuse, concomitant medication * More than four hours of physical exercise per week * Women who are pregnant, breast-feeding or aiming to become pregnant during course of the trial * Women and men on hormonal supplementation * Women with an irregular menstrual cycle according to the FIGO criteria * Therapy with antidepressants within the past 6 months * Regular therapy with acetylsalicyclic acid or current medication to regulate blood sugar, blood pressure or lipids * Participants likely to fail to comply with the study protocol * Participants who do not give informed consent
Where this trial is running
Zurich, Canton of Zurich
- Department of Endocrinology, Diabetology and Clinical Nutrition — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Philipp Gerber, MD — University of Zurich
- Study coordinator: Leonie Mönch, MSc
- Email: leonie.moench@usz.ch
- Phone: +41 44 255 31 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.