Intermittent Fasting for Overweight Individuals - Effects on Health
Descrizione riassuntiva dello studio
The prevalence of overweight and obesity has significantly increased worldwide over the past century. People in modern societies typically eat at least three main meals a day and snacks around the clock. This eating behavior can lead to excessive consumption and subsequently to overweight and metabolic diseases (e.g., diabetes and cardiovascular diseases). In recent years, intermittent fasting (IF) has emerged as a new and effective method for weight loss and health improvement. Intermittent fasting is a dietary pattern where eating and fasting alternate. There are different types, such as Time-Restricted Eating (TRE) or Alternate Day Fasting (ADF). In TRE, individuals eat at will during a specific time window per day (4-8h) and fast for the remaining time (16-20h). In the ADF method, eating and fasting days alternate. One eats at will on one day and then fasts for 36 hours until the next day. So far, intervention studies have focused on comparing one type of intermittent fasting with a control group, but few studies have directly compared different IF protocols with each other. Such comparative studies are important to highlight potential differences in their effectiveness. The aim of this study is to compare two different types of intermittent fasting (ADF and TRF) with each other and with a control group. Participants will be randomly assigned to the groups and will follow the assigned dietary form for 8 weeks. The findings of this study are intended to contribute to the future application of these approaches in clinical settings, thereby improving patient care.
(BASEC)
Intervento studiato
All participants receive recommendations for a healthy diet. This study consists of an observation week and a subsequent 8-week intervention. Participants are randomly assigned to three different groups: - Time-Restricted Eating (TRE): In the TRE group, participants are allowed to consume two main meals within an 8-hour time window (12:00-20:00) and must fast for 16 hours (water and unsweetened tea or black coffee are allowed). - modified Alternate Day Fasting (mADF): In the mADF group, participants can eat at will one day and must fast the next day (water and unsweetened tea or black coffee are allowed). On the evening of the fasting day, participants are to consume a snack provided by the study team. - Control group: Participants receive recommendations for a qualitative reduction of total calorie intake through a balanced, carbohydrate-reduced diet. In the control group, participants should not change the time window in which they eat. Before and after the intervention, a larger examination takes place, including a whole-body MRI (magnetic resonance imaging) and a blood draw. Additionally, weight and height are measured, and breathing measurements are conducted. During the intervention, we measure various parameters in real-time using a glucose sensor and an activity tracker. They are also asked to keep a 4-day dietary log three times. For participants, the study lasts 9 weeks.
(BASEC)
Malattie studiate
This clinical study investigates the effects of intermittent fasting on the health of overweight adults.
(BASEC)
- 18 to 50 years old - BMI between 30 and 40 kg/m2 - Non-smokers (BASEC)
Criteri di esclusione
- Adults fasting more than 12 hours per day and not consuming at least three main meals per day - Acute or chronic diseases - More than 4 hours of exercise per week (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Philipp Gerber
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Philipp Gerber
+41 44 255 36 20
philipp.gerber@clutterusz.chKlinik für Endokrinologie, Diabetologie und Klinische Ernährung Universitätsspital Zürich Rämistrasse 100 8091 Zürich
(BASEC)
Informazioni scientifiche
University of Zurich,
+41 44 255 31 64;
philipp.gerber@clutterusz.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
07.11.2023
(BASEC)
ID di studio ICTRP
NCT06323889 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Longitudinal Monitoring during different Intermittent Fasting Protocols in Obese Adults – A Randomized Clinical Trial (BASEC)
Titolo accademico
Longitudinal Monitoring During Different Intermittent Fasting Protocols in Obese Adults - a Randomized Clinical Trial (ICTRP)
Titolo pubblico
Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults (ICTRP)
Malattie studiate
Intermittent Fasting;Obesity;Time Restricted Eating (ICTRP)
Intervento studiato
Behavioral: Modified Alternate Day Fasting;Behavioral: Time-Restricted Eating;Behavioral: Weight-loss counseling (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Gender: All
Maximum age: 50 Years
Minimum age: 18 Years
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 (ICTRP)
non disponibile
Endpoint primari e secondari
Fat Volume (ICTRP)
Distribution of fat volume;Concentration of Leptin;Changes in Insulin Sensitivity;Changes in Fasting Lipids;Changes in Inflammatory Markers;Free triiodothyronine (fT3) (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Philipp Gerber, MD;Leonie M?nch, MSc;Philipp Gerber, MD, leonie.moench@usz.ch, +41 44 255 31 64;, University of Zurich, (ICTRP)
ID secondari
LIMITFOOD2 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06323889 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile