Status:
COMPLETED
Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults
Lead Sponsor:
Philipp Gerber
Conditions:
Intermittent Fasting
Overweight
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
LIMITFOOD 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 normal- and overweight ...
Detailed Description
The prevalence of overweight has risen considerably all over the world in the past century. Epidemiological studies have shown that, starting from a body mass index of 20-21 kg/m2, increasing BMI leve...
Eligibility Criteria
Inclusion
- Age between 18-40 years, both inclusive
- Non-obese, BMI between 23 and 30 kg/m2, both inclusive
- Non-smoker
- Good knowledge of German or English language
- Stable weight change (change \< +/- 10% current bodyweight) for 3 months prior to the study
- Glycohemoglobin (HbA1c) \< 5.7% without glucose lowering medication
- LDL-cholesterol \< 180 mg/dl without lipid lowering medication
- Blood pressure \< 140/90 mmHG without blood pressure lowering medication
Exclusion
- Subjects 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
- Food intolerances, allergies and sensitivities (e.g. lactose/gluten intolerance, 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 a very irregular menstrual cycle
- Therapy with antidepressants within the past 6 months
- Regular therapy with acetylsalicyclic acid or current medication to regulate blood sugar, blood pressure or lipids
- Subjects likely to fail to comply with the study protocol
- Subjects who do not give informed consent
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04732130
Start Date
March 10 2021
End Date
July 1 2023
Last Update
October 6 2023
Active Locations (1)
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1
Department of Endocrinology, Diabetology and Clinical Nutrition
Zurich, Switzerland, 8091