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NCT Number: NCT06885255

Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome

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.

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Key information

Conditions

Metabolic Syndrome Behavior Body Weight Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity and Obesity-related Medical Conditions Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Location status: Recruiting

Location contact

Prof. Dr. med. Yurdagül Zopf

CONTACT

[email protected]

0049091318545220

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alternate day fasting

Other

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 eating

Other

Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.

High-intensity interval training

Other

Patients participate in high-intensity interval training.

Primary outcomes

  1. hsCRP

    Time frame: From enrollment to the end of intervention at 3 months.

    High sensitivity C-reactive protein in mg/l.

Secondary outcomes

  1. inflammatory markers and metabolic markers

    Time frame: From enrollment to the end of intervention at 3 months.

    Determination of inflammatory markers and metabolic markers in blood (e.g., sICAM-1, IGF-1, β-hydroxybutyrate, estrogens, androgens).

  2. waist circumference

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of waist circumference in centimeters (cm).

  3. fasting blood glucose

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of fasting blood glucose in milligrams per deciliter (mg/dL).

  4. triglycerides

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of triglycerides in milligrams per deciliter (mg/dL).

  5. cholesterol

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of cholesterol (total, LDL, HDL) in milligrams per deciliter (mg/dL).

  6. blood pressure

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of systolic and diastolic blood pressure in millimeters of mercury (mmHg).

  7. cardiometabolic risk profile

    Time frame: From enrollment to the end of intervention at 3 months.

    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.

  8. maximal oxygen uptake

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of maximal oxygen uptake (VO2max) via spiroergometry.

  9. liver fat status

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of liver fat status via ultrasound examination.

  10. composition of the intestinal and oral microbiome

    Time frame: From enrollment to the end of intervention at 3 months.

    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.

  11. skin microbiome

    Time frame: From enrollment to the end of intervention at 3 months.

    Determination of the composition of the skin microbiome.

  12. cortisol

    Time frame: From enrollment to the end of intervention at 3 months.

    Detection of cortisol from 24-hour urine collection.

  13. body weight

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of body weight in kilograms (kg) using bioimpedance analysis.

  14. body fat percentage

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of body fat percentage (%) using bioimpedance analysis.

  15. fat-free mass

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of fat-free mass (in kilograms) using bioimpedance analysis.

  16. muscle mass

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of muscle mass (in kilograms) using bioimpedance analysis.

  17. phase angle

    Time frame: From enrollment to the end of intervention at 3 months.

    Measurement of phase angle (in degrees) using bioimpedance analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. med. Yurdagül Zopf

CONTACT

[email protected]

0049091318545220

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study 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

Acronym: FIT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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