Clinical trial NCT06885255: Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Obesity and Obesity-related Medical Conditions
Keywords: obesity
metabolic syndrome
high-intensity interval training
inflammation
intermittent fasting
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Written consent to participate in the study.
* Persons aged 18 years and older.
* Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: hsCRP
timeFrame: From enrollment to the end of intervention at 3 months.
Secondary outcomes:
measure: inflammatory markers and metabolic markers
timeFrame: From enrollment to the end of intervention at 3 months.
measure: waist circumference
timeFrame: From enrollment to the end of intervention at 3 months.
measure: fasting blood glucose
timeFrame: From enrollment to the end of intervention at 3 months.
measure: triglycerides
timeFrame: From enrollment to the end of intervention at 3 months.
measure: cholesterol
timeFrame: From enrollment to the end of intervention at 3 months.
measure: blood pressure
timeFrame: From enrollment to the end of intervention at 3 months.
measure: cardiometabolic risk profile
timeFrame: From enrollment to the end of intervention at 3 months.
measure: maximal oxygen uptake
timeFrame: From enrollment to the end of intervention at 3 months.
measure: liver fat status
timeFrame: From enrollment to the end of intervention at 3 months.
measure: composition of the intestinal and oral microbiome
timeFrame: From enrollment to the end of intervention at 3 months.
measure: skin microbiome
timeFrame: From enrollment to the end of intervention at 3 months.
measure: cortisol
timeFrame: From enrollment to the end of intervention at 3 months.
measure: body weight
timeFrame: From enrollment to the end of intervention at 3 months.
measure: body fat percentage
timeFrame: From enrollment to the end of intervention at 3 months.
measure: fat-free mass
timeFrame: From enrollment to the end of intervention at 3 months.
measure: muscle mass
timeFrame: From enrollment to the end of intervention at 3 months.
measure: phase angle
timeFrame: From enrollment to the end of intervention at 3 months.
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen
state: Bavaria
Study officials:
References: