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RECRUITINGINTERVENTIONAL

Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults

Longitudinal Monitoring During Different Intermittent Fasting Protocols in Obese Adults - a Randomized Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Modified Alternate Day Fasting

Participants are instructed to fast every other day.

BEHAVIORAL

Time-Restricted Eating

Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day

BEHAVIORAL

Weight-loss counseling

Participants will receive nutrition counseling to structure their main meals according to the plate model for weight-loss and to reduce number of consumed plates.

Locations (1)

Department of Endocrinology, Diabetology and Clinical Nutrition
Zurich, Canton of Zurich, Switzerland