Actively Recruiting
Longitudinal Monitoring During Different Intermittent Fasting Protocols in Obese Adults - a Randomized Clinical Trial
Led by University of Zurich · Updated on 2024-12-20
90
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of two different intermittent fasting methods compared to a control group on the health of obese adults. This randomized clinical trial focuses on adults aged 18 to 50 with obesity, aiming to understand how different fasting schedules may impact weight and metabolic health. The study also explores new ways to monitor progress during intermittent fasting, which has grown popular as a dietary approach to manage weight and improve health markers. Participants are divided into three groups: one follows a modified alternate day fasting (mADF) protocol where they eat freely every other day and consume a very low carbohydrate snack only in the evening on fasting days; another group practices time-restricted eating (TRE), limiting food intake to two main meals between 12:00 and 20:00 daily and fasting outside these hours; the third group receives general weight-loss counseling without food timing restrictions. The study will last 8 weeks, comparing these approaches side-by-side. During the study, participants will be regularly assessed for changes in fat volume, fat distribution, leptin concentration, insulin sensitivity, fasting lipids, inflammatory markers, and free triiodothyronine levels. These measurements help track the effects of the fasting protocols on body composition and metabolic health. The trial includes detailed monitoring of individual progress and adherence, with all groups receiving follow-up over the 8-week period to evaluate outcomes and safety.
CONDITIONS
Brief Title
Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years
- Obese with a BMI between 30 and 40 kg/m2 (obesity grade I or II)
- Non-smoker
- Good knowledge of German or English
- Stable weight change less than +/- 3% over the past 3 months
- HbA1c below 6.5% without glucose lowering medication
- LDL-cholesterol below 4.6 mmol/l without lipid lowering medication
You will not qualify if you...
- Regular fasting periods longer than 12 hours per day or eating fewer than three main meals daily
- Current use of dietary supplements or unwillingness to stop their use
- Antibiotics use within 3 months before the study
- Food intolerances, severe allergies, or dietary restrictions such as veganism
- Acute or chronic infections, cancer, kidney, liver, lung, neurological, psychiatric diseases, or serious cardiovascular conditions
- Diabetes
- Known alcohol, substance, or drug abuse, or taking certain medications
- More than four hours of physical exercise per week
- Pregnancy, breastfeeding, or planning pregnancy during the trial
- Hormonal supplementation
- Irregular menstrual cycle according to FIGO criteria
- Antidepressant therapy within the past 6 months
- Regular use of aspirin or medications for blood sugar, blood pressure, or lipids
- Likely inability to follow the study protocol
- Not giving informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants follow one of three dietary protocols: Modified Alternate Day Fasting (mADF), Time-Restricted Eating (TRE), or receive weight-loss counseling. They will adhere to their assigned eating schedules and nutritional guidance during this period.
Weekly visits for 8 weeks
Duration - Up to 8 weeks after treatment
Participants are monitored to assess changes in fat volume, metabolic and inflammatory markers after the treatment period.
1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Diabetology and Clinical Nutrition
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
L
Leonie Mönch, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here