Intermittent FastingLIMITFOOD2NCT06323889
Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults
A study testing Modified Alternate Day Fasting, Time-Restricted Eating and Weight-loss counseling in people with Intermittent Fasting and Obesity, run by University of Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting, Obesity, Time Restricted Eating
- What is being tested?
- Modified Alternate Day Fasting, Time-Restricted Eating and Weight-loss counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Sep 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Diabetology and Clinical Nutrition
Zurich, Canton of Zurich, 8091
Philipp Gerber, MD
Nina Derron, PhD
About this study
Official title: Longitudinal Monitoring During Different Intermittent Fasting Protocols in Obese Adults - a Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Intermittent Fasting, Obesity, Time Restricted Eating
- Being tested
- Modified Alternate Day Fasting, Time-Restricted Eating, Weight-loss counseling
- Keywords
- Overnutrition, Nutrition Disorders, Body Weight, Obesity, Longitudinal monitoring
- Medical subject headings
- Intermittent Fasting, Obesity, Overnutrition, Nutrition Disorders, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Alternate Day FastingBehavioural
Participants are instructed to fast every other day.
Time-Restricted EatingBehavioural
Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day
Weight-loss counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Modified Alternate Day Fasting |
| 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 Receives: Behavioral: Time-Restricted Eating |
| 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. Receives: Behavioral: Weight-loss counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Volume
Change in body fat volume measured with MRI
Measured: 8 weeks
Secondary outcomes (6)
Distribution of fat volume
Changes in subcutaneous and visceral fat volume measured with MRI
Measured: 8 weeks
Concentration of Leptin
Change in leptin concentrations will be measured.
Measured: 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.
Measured: 8 weeks
Changes in Fasting Lipids
Changes in concentration of Apolipoprotein B and triglycerides will be measured from a 12 hours fasting blood sample.
Measured: 8 weeks
Changes in Inflammatory Markers
Changes in concentration of C-reactive protein and Interleukin-1beta will be measured.
Measured: 8 weeks
Free triiodothyronine (fT3)
Change in serum levels of fT3 will be measured.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start23 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Gerber, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323889
- Sponsor's protocol ID
- LIMITFOOD2
- Acronym
- LIMITFOOD2
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring During Different Intermittent Fasting Protocols in Obese Adults - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06323889
- Acronym / sponsor ID
- LIMITFOOD2 / LIMITFOOD2
- Conditions
- Intermittent Fasting, Obesity, Time Restricted Eating
- Keywords
- Overnutrition, Nutrition Disorders, Body Weight, Obesity, Longitudinal monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Modified Alternate Day Fasting (mADF) | Active comparator | Behavioral: Modified Alternate Day FastingParticipants 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. |
| Time-Restricted Eating (TRE) | Active comparator | Behavioral: Time-Restricted EatingTRE 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 |
| Control group | Other | Behavioral: Weight-loss counselingThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Alternate Day FastingParticipants are instructed to fast every other day. | Behavioural | Modified Alternate Day Fasting (mADF) |
| Time-Restricted EatingParticipants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day | Behavioural | Time-Restricted Eating (TRE) |
| Weight-loss counselingParticipants will receive nutrition counseling to structure their main meals according to the plate model for weight-loss and to reduce number of consumed plates. | Behavioural | Control group |
Primary outcome
Fat Volume
Time frame: 8 weeks
Change in body fat volume measured with MRI
6 secondary outcomes
Distribution of fat volume
Time frame: 8 weeks
Concentration of Leptin
Time frame: 8 weeks
Changes in Insulin Sensitivity
Time frame: 8 weeks
Changes in Fasting Lipids
Time frame: 8 weeks
Changes in Inflammatory Markers
Time frame: 8 weeks
Free triiodothyronine (fT3)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Gerber, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Alternate Day Fasting, Time-Restricted Eating and Weight-loss counseling in people with Intermittent Fasting and Obesity, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leonie Mönch, MSc (+41 44 255 31 64, leonie.moench@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Volume (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.