Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults
NCT ID: NCT06323889
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2024-09-23
2027-01-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified Alternate Day Fasting (mADF)
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.
Modified Alternate Day Fasting
Participants are instructed to fast every other day.
Time-Restricted Eating (TRE)
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
Time-Restricted Eating
Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day
Control group
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.
Weight-loss counseling
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.
Interventions
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Modified Alternate Day Fasting
Participants are instructed to fast every other day.
Time-Restricted Eating
Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day
Weight-loss counseling
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Philipp Gerber, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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Department of Endocrinology, Diabetology and Clinical Nutrition
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Philipp Gerber, MD
Role: primary
Nina Derron, PhD
Role: backup
Johanna Zehnder, MSc
Role: backup
Other Identifiers
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LIMITFOOD2
Identifier Type: -
Identifier Source: org_study_id