Modified Alternate Day FastingTime-Restricted EatingWeight-loss counseling
Modified Alternate Day Fasting: Participants are instructed to fast every other day.
Time-Restricted Eating: Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Fat Volume — 8 weeks Change in body fat volume measured with MRI
Trial sites (1)
Facility
City
Region
Status
Department of Endocrinology, Diabetology and Clinical Nutrition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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