Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults
Recruiting · NCT06323889 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Modified Alternate Day FastingTime-Restricted EatingWeight-loss counseling
What this trial is about
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 can take part
Age range
18 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Department of Endocrinology, Diabetology and Clinical Nutrition - Zurich, Canton of Zurich, Switzerland