Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults

ConditionsIntermittent Fasting Obesity Time Restricted Eating

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-50

SponsorUniversity of Zurich

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18-50 years, both inclusive

Obese, BMI between 30 and 40 kg/m² (obesity grade I or II), both inclusive

Non-smoker

Good knowledge of German or English language

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Modified Alternate Day Fasting
Behavioral
Participants are instructed to fast every other day.
Time-Restricted Eating
Behavioral
Participants are instructed to limit food intake to two main meals consumed in maximum 8 hours per day
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.

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Modified Alternate Day Fasting (mADF)Active comparator 1 intervention

Group B: Time-Restricted Eating (TRE)Active comparator 1 intervention

Group C: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

Fat Volume

Change in body fat volume measured with MRI

Time frame

8 weeks

Secondary outcomes

Distribution of fat volume

Changes in subcutaneous and visceral fat volume measured with MRI

Time frame

8 weeks

Concentration of Leptin

Change in leptin concentrations will be measured.

Time frame

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.

Time frame

8 weeks

Changes in Fasting Lipids

Changes in concentration of Apolipoprotein B and triglycerides will be measured from a 12 hours fasting blood sample.

Time frame

8 weeks

Other outcomes

Correlation of longitudinally measured parameters

Breath acetone measurements and continuous glucose monitoring will be conducted and correlated to the fat volume change.

Time frame

8 weeks

Serum Metabolomics

Metabolomics provides an insight into the organisms current metabolite profile. Exploring the effect of intermittent fasting on specific metabolites could provide important insights.

Time frame

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.

Time frame

8 weeks

LDL Particle Size

Changes in serum LDL particle size might be measured.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Source ClinicalTrials.gov

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