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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Written consent to participate in the study.

Persons aged 18 years and older.

Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alternate day fasting

    Other intervention

    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 intervention

    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 intervention

    Patients participate in high-intensity interval training.

Treatment groups

250 Participants
are divided into 5 treatment groups
Group A: Metabolic syndrome - alternate day fastingExperimental treatment 1 intervention
Group B: Metabolic syndrome - time restricted eatingExperimental treatment 1 intervention
Group C: Metabolic syndrome - time restricted eating plus high-intensity interval trainingExperimental treatment 2 interventions
Group D: Metabolic syndrome - controlsNo intervention 0 interventions
Group E: Healthy - controlsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

hsCRP

High sensitivity C-reactive protein in mg/l.

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

Secondary outcomes

1

inflammatory markers and metabolic markers

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

Time frame
From enrollment to the end of intervention at 3 months.
2

waist circumference

Measurement of waist circumference in centimeters (cm).

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

fasting blood glucose

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

Time frame
From enrollment to the end of intervention at 3 months.
4

triglycerides

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

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

Other outcomes

Sponsors and contacts

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