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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.
The prevalence of overweight and obesity worldwide has risen considerably in the past century with more than one billion overweight persons, and about 600 million obese patients in 2015. Humans in modern societies typically eat at least three main meals per day and snacks around the clock. This change in eating pattern in terms of quantity and frequency leads to overconsumption of food and consequently to excess weight. Furthermore, obesity increases the risk of developing diabetes, cardiovascular disease and several types of cancer. The world health organization (WHO) has stated that there are 2.8 million deaths per year as a result of overweight and obesity.
In recent years, the concept of re-introduced fasting intervals in the form of intermittent fasting (IF) protocols became a popular alternative dietary strategy with the aim to achieve weight control and improve metabolic health. There are several different IF protocols, the most popular is time-restricted eating (TRE), which allows ad libitum (at one's pleasure) energy intake within a defined time period each time (6 to 12 hours). Another IF protocol is alternate day fasting (ADF), on 'feast days' one can consume food ad libitum, while on 'fast days' no or little food is consumed, feast and fast days alternate throughout the week. Animal studies and previous human clinical trials have provided evidence that various types of IF lead to weight loss and improved health markers. So far, interventional studies focused on the comparison of IF versus a control group, however only few studies compared different IF protocols directly. Given both the evidence for beneficial effects of IF as well as its growing popularity, it seems mandatory to reveal possible differences in the effectiveness of different protocols.
The present project will allow to directly compare two types of IF with each other and with a control group in obese participants. Furthermore, established and novel monitoring tools to track individual progress during IF are scarcely used so far but may become an important help in the future and thus, will be implemented in this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Alternate Day Fasting (mADF) | Active Comparator | Participants in the mADF group will be instructed to eat every second-day ad libitum ("feast days"), and to consume a very low carbohydrate snack, restricted to the evening, provided by the study team and to otherwise abstain from calorie intake on the rest of the fast day. |
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| Time-Restricted Eating (TRE) | Active Comparator | TRE participants are instructed to eat two main meals and limit snacking from 12:00 to 20:00 daily, and to fast from 20:00 until 12:00 daily |
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| Control group | Other | The control group will receive guidance on a quantitative reduction in total caloric intake by following a balanced diet, but no timing window for food intake will be prescribed to the participants in the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Alternate Day Fasting | Behavioral | Participants are instructed to fast every other day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Fat Volume | Change in body fat volume measured with MRI | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of fat volume | Changes in subcutaneous and visceral fat volume measured with MRI | 8 weeks |
| Concentration of Leptin | Change in leptin concentrations will be measured. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of longitudinally measured parameters | Breath acetone measurements and continuous glucose monitoring will be conducted and correlated to the fat volume change. | 8 weeks |
| Serum Metabolomics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonie Mönch, MSc | Contact | +41 44 255 31 64 | leonie.moench@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Philipp Gerber, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Diabetology and Clinical Nutrition | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D009765 | Obesity |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D050177 | Overweight |
| D009750 |
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| Time-Restricted Eating | Behavioral | Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day |
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| Weight-loss counseling | Behavioral | 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. |
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| 8 weeks |
| Changes in Insulin Sensitivity | Insulin Sensitivity will be assessed using the homeostasis model assessment of insulin resistance (HOMA-IR), which is calculated from insulin and glucose concentration from a 12 hours fasting blood sample. | 8 weeks |
| Changes in Fasting Lipids | Changes in concentration of Apolipoprotein B and triglycerides will be measured from a 12 hours fasting blood sample. | 8 weeks |
| Changes in Inflammatory Markers | Changes in concentration of C-reactive protein and Interleukin-1beta will be measured. | 8 weeks |
| Free triiodothyronine (fT3) | Change in serum levels of fT3 will be measured. | 8 weeks |
Metabolomics provides an insight into the organisms current metabolite profile. Exploring the effect of intermittent fasting on specific metabolites could provide important insights.
| 8 weeks |
| Genetic Analysis | Genes associated with obesity could have an effect on the efficacy of the intermittent fasting intervention and genetic analysis may provide an important step towards personalized medicine. | 8 weeks |
| LDL Particle Size | Changes in serum LDL particle size might be measured. | 8 weeks |
| Fecal Microbiome | Sequencing will be used to identify the composition of bacteria and archaea within the fecal samples. Exploring the changes in the microbiome induced by intermittent fasting could provide valuable insights. | 8 weeks |
| Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |