Monitoring health effects of intermittent fasting in obese adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.