๐ฌIn plain words
What the trial is, and whether it could suit you
LIMITFOOD2 is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of obese adults. A total of 90 participants will be randomized into three equally sized groups: a modified alternate day fasting, a time-restricted eating and a control group, receiving general weight-loss counseling.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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