- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04732130
Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults (LIMITFOOD)
Longitudinal Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults - A Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
The prevalence of overweight has risen considerably all over the world in the past century. Epidemiological studies have shown that, starting from a body mass index of 20-21 kg/m2, increasing BMI levels are associated with progressively increased risks of developing diabetes, cardiovascular disease, several types of cancer and other diseases. The problem is pronounced by the unlimited and constant availability of food. Treatment of overweight is still difficult and finding effective and more personalized strategies to manage these conditions is crucial.
Intermittent fasting has been suggested as an alternative way to address these problems. Intermittent fasting is an eating pattern that involves rotating periods of eating and fasting. Animal studies and previous human clinical trials have provided evidence that various types of intermittent fasting lead to weight loss and improved health markers not only in obese, but also in healthy, non-obese adults.There are several types of intermittent fasting. The most popular version is time-restricted feeding (TRF), which allows ad libitum (at one's pleasure) energy intake within a defined period of time each day (6-12h). Another subtype of IF is called alternate day fasting (ADF). ADF is defined as 'feast days' on which food is consumed ad libitum, which alternate with 'fast days' on which food is withheld or reduced.
However, despite the growing popularity of intermittent fasting, it is not clear which type of IF is most effective and what fasting window is needed to induce beneficial effects. Additionally, tools to longitudinally track personal progress of dieting are lacking. Therefore, the main objective of this study is to compare the effects of each of two different intermittent fasting protocols (TRF and ADF) on metabolic parameters to a control group. Furthermore, a new dynamic measurement technique, using breath analysis, will allow to better monitor the progress of individual participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zürich, Switzerland, 8091
- Department of Endocrinology, Diabetology and Clinical Nutrition
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18-40 years, both inclusive
- Non-obese, BMI between 23 and 30 kg/m2, both inclusive
- Non-smoker
- Good knowledge of German or English language
- Stable weight change (change < +/- 10% current bodyweight) for 3 months prior to the study
- Glycohemoglobin (HbA1c) < 5.7% without glucose lowering medication
- LDL-cholesterol < 180 mg/dl without lipid lowering medication
- Blood pressure < 140/90 mmHG without blood pressure lowering medication
Exclusion Criteria:
- Subjects 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
- Food intolerances, allergies and sensitivities (e.g. lactose/gluten intolerance, 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 a very irregular menstrual cycle
- Therapy with antidepressants within the past 6 months
- Regular therapy with acetylsalicyclic acid or current medication to regulate blood sugar, blood pressure or lipids
- Subjects likely to fail to comply with the study protocol
- Subjects who do not give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Time-Restricted Feeding
Participants in the time-restricted feeding are instructed to eat ad libitum from 12:00 to 20:00 daily, and fast from 20:00 to 12:00 daily for 4 weeks.
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Participants are instructed to limit food intake to maximum 8 hours per day.
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Active Comparator: Alternate Day Fasting
Participants in the alternate day fasting group are instructed to eat every second day ad libitum, but to abstain from calorie intake on fast days (100 % restriction) for 4 weeks.
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Participants are instructed to fast every other day.
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No Intervention: Control
Participants in the control group are instructed to maintain their habitual diet regimen.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat mass
Time Frame: 4 weeks
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Change in whole body fat mass
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous glucose monitoring (CGM)
Time Frame: 4 weeks
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During the study period the CGM system will measure the continuous glucose concentration of the participants and thereby any changes will be measured.
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4 weeks
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Physical activity energy expenditure
Time Frame: 4 weeks
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Change in mean physical activity energy expenditure will be recorded using an Actiheart monitor during the intervention.
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4 weeks
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Resting metabolic rate (measured by indirect calorimetry)
Time Frame: 4 weeks
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Change in resting metabolic rate
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philipp Gerber, MD, University of Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIMITFOOD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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