Metabolic SyndromeFITNCT06885255
Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome
A study testing Alternate day fasting, Time restricted eating and High-intensity interval training in people with Metabolic Syndrome and Obesity and Obesity-related Medical Conditions, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity and Obesity-related Medical Conditions
- What is being tested?
- Alternate day fasting, Time restricted eating and High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2023to Mar 2026
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written consent to participate in the study.
- Persons aged 18 years and older.
- Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.
Who cannot join
- Pregnant or nursing individuals.
- Cardiovascular diseases or orthopedic restrictions that prevent exercise.
- Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).
- Body weight greater than 200 kg (maximum capacity of training equipment).
- Individuals with mental illnesses that may impair their ability to understand or participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen
Erlangen, Bavaria, 91054
Prof. Dr. med. Yurdagül Zopf, 0049091318545220, hectorcenter.m1@uk-erlangen.de
About this study
Official title: Effects of Intermittent Fasting and Its Combination with High-Intensity Interval Training on Inflammatory and Metabolic Markers, As Well As the Microbiome in Patients with Metabolic Syndrome: a Randomized Controlled Pilot Study
The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is:
Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome?
Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.
- Being tested
- Alternate day fasting, Time restricted eating, High-intensity interval training
- Keywords
- obesity, metabolic syndrome, high-intensity interval training, inflammation, intermittent fasting
- Medical subject headings
- Metabolic Syndrome, Obesity, Inflammation, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate day fastingOther
Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.
Time restricted eatingOther
Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.
High-intensity interval trainingOther
Patients participate in high-intensity interval training.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic syndrome - alternate day fasting | Experimental | Patients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet Receives: Other: Alternate day fasting |
| Metabolic syndrome - time restricted eating | Experimental | Patients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet Receives: Other: Time restricted eating |
| Metabolic syndrome - time restricted eating plus high-intensity interval training | Experimental | Patients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet Receives: Other: Time restricted eating; Other: High-intensity interval training |
| Metabolic syndrome - controls | No intervention | Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet |
| Healthy - controls | No intervention | Healthy controls exclusively receiving regular advice on the mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP
High sensitivity C-reactive protein in mg/l.
Measured: From enrollment to the end of intervention at 3 months.
Secondary outcomes (17)
inflammatory markers and metabolic markers
Determination of inflammatory markers and metabolic markers in blood (e.g., sICAM-1, IGF-1, β-hydroxybutyrate, estrogens, androgens).
Measured: From enrollment to the end of intervention at 3 months.
waist circumference
Measurement of waist circumference in centimeters (cm).
Measured: From enrollment to the end of intervention at 3 months.
fasting blood glucose
Measurement of fasting blood glucose in milligrams per deciliter (mg/dL).
Measured: From enrollment to the end of intervention at 3 months.
triglycerides
Measurement of triglycerides in milligrams per deciliter (mg/dL).
Measured: From enrollment to the end of intervention at 3 months.
cholesterol
Measurement of cholesterol (total, LDL, HDL) in milligrams per deciliter (mg/dL).
Measured: From enrollment to the end of intervention at 3 months.
blood pressure
Measurement of systolic and diastolic blood pressure in millimeters of mercury (mmHg).
Measured: From enrollment to the end of intervention at 3 months.
cardiometabolic risk profile
Calculation of the MetS z-score by combining waist circumference, fasting blood glucose, triglycerides, cholesterol, and blood pressure. The z-score will be reported as a single value based on these separate measures.
Measured: From enrollment to the end of intervention at 3 months.
maximal oxygen uptake
Measurement of maximal oxygen uptake (VO2max) via spiroergometry.
Measured: From enrollment to the end of intervention at 3 months.
liver fat status
Measurement of liver fat status via ultrasound examination.
Measured: From enrollment to the end of intervention at 3 months.
composition of the intestinal and oral microbiome
Determination of the composition of the intestinal and oral microbiome by sequencing bacterial 16sRNA on the MiSeq platform, as well as analysis of the stool metabolome.
Measured: From enrollment to the end of intervention at 3 months.
skin microbiome
Determination of the composition of the skin microbiome.
Measured: From enrollment to the end of intervention at 3 months.
cortisol
Detection of cortisol from 24-hour urine collection.
Measured: From enrollment to the end of intervention at 3 months.
body weight
Measurement of body weight in kilograms (kg) using bioimpedance analysis.
Measured: From enrollment to the end of intervention at 3 months.
body fat percentage
Measurement of body fat percentage (%) using bioimpedance analysis.
Measured: From enrollment to the end of intervention at 3 months.
fat-free mass
Measurement of fat-free mass (in kilograms) using bioimpedance analysis.
Measured: From enrollment to the end of intervention at 3 months.
muscle mass
Measurement of muscle mass (in kilograms) using bioimpedance analysis.
Measured: From enrollment to the end of intervention at 3 months.
phase angle
Measurement of phase angle (in degrees) using bioimpedance analysis.
Measured: From enrollment to the end of intervention at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Jun 2023
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yurdagül zopf, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885255
- Sponsor's protocol ID
- 22-60_2-B
- Acronym
- FIT
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 20 Mar 2025
- 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 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Fasting and Its Combination with High-Intensity Interval Training on Inflammatory and Metabolic Markers, As Well As the Microbiome in Patients with Metabolic Syndrome: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06885255
- Acronym / sponsor ID
- FIT / 22-60_2-B
- Keywords
- obesity, metabolic syndrome, high-intensity interval training, inflammation, intermittent fasting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 20 Mar 2025 (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.
The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is:
Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome?
Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Metabolic syndrome - alternate day fasting | Experimental | Other: Alternate day fastingPatients with metabolic syndrome who undergo alternate-day fasting in addition to regular advice on the mediterranean diet |
| Metabolic syndrome - time restricted eating | Experimental | Other: Time restricted eatingPatients with metabolic syndrome who undergo time restricted eating in addition to regular advice on the mediterranean diet |
| Metabolic syndrome - time restricted eating plus high-intensity interval training | Experimental | Other: Time restricted eating, Other: High-intensity interval trainingPatients with metabolic syndrome who undergo time restricted eating plus high-intensity interval training in addition to regular advice on the mediterranean diet |
| Metabolic syndrome - controls | No intervention | –Patients with metabolic syndrome exclusively receiving regular advice on the mediterranean diet |
| Healthy - controls | No intervention | –Healthy controls exclusively receiving regular advice on the mediterranean diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written consent to participate in the study.
- Persons aged 18 years and older.
- Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.
Key exclusion criteria (5 listed)
- Pregnant or nursing individuals.
- Cardiovascular diseases or orthopedic restrictions that prevent exercise.
- Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).
- Body weight greater than 200 kg (maximum capacity of training equipment).
- Individuals with mental illnesses that may impair their ability to understand or participate 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 |
|---|---|---|
| Alternate day fastingParticipants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day. | Other | Metabolic syndrome - alternate day fasting |
| Time restricted eatingSubjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours. | Other | Metabolic syndrome - time restricted eating, Metabolic syndrome - time restricted eating plus high-intensity interval training |
| High-intensity interval trainingPatients participate in high-intensity interval training. | Other | Metabolic syndrome - time restricted eating plus high-intensity interval training |
Primary outcome
hsCRP
Time frame: From enrollment to the end of intervention at 3 months.
High sensitivity C-reactive protein in mg/l.
17 secondary outcomes
inflammatory markers and metabolic markers
Time frame: From enrollment to the end of intervention at 3 months.
waist circumference
Time frame: From enrollment to the end of intervention at 3 months.
fasting blood glucose
Time frame: From enrollment to the end of intervention at 3 months.
triglycerides
Time frame: From enrollment to the end of intervention at 3 months.
cholesterol
Time frame: From enrollment to the end of intervention at 3 months.
blood pressure
Time frame: From enrollment to the end of intervention at 3 months.
cardiometabolic risk profile
Time frame: From enrollment to the end of intervention at 3 months.
maximal oxygen uptake
Time frame: From enrollment to the end of intervention at 3 months.
liver fat status
Time frame: From enrollment to the end of intervention at 3 months.
composition of the intestinal and oral microbiome
Time frame: From enrollment to the end of intervention at 3 months.
skin microbiome
Time frame: From enrollment to the end of intervention at 3 months.
cortisol
Time frame: From enrollment to the end of intervention at 3 months.
body weight
Time frame: From enrollment to the end of intervention at 3 months.
body fat percentage
Time frame: From enrollment to the end of intervention at 3 months.
fat-free mass
Time frame: From enrollment to the end of intervention at 3 months.
muscle mass
Time frame: From enrollment to the end of intervention at 3 months.
phase angle
Time frame: From enrollment to the end of intervention at 3 months.
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 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate day fasting, Time restricted eating and High-intensity interval training in people with Metabolic Syndrome and Obesity and Obesity-related Medical Conditions, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 3 inclusion and 5 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 Mar 2025. 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 Germany. 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 Prof. Dr. med. Yurdagül Zopf (0049091318545220, yurdaguel.zopf@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hsCRP (time frame: From enrollment to the end of intervention at 3 months.). 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 Mar 2025.