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The impact of a very-low-carbohydrate Diet on human T-cell immunometabolism

The impact of a very-low-carbohydrate Diet on human T-cell immunometabolism - Keto-T-response

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027992
Enrollment
810
Registered
2022-02-01
Start date
2021-10-18
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ketogenic diet, low-carb, immunonutrition, chronic inflammation, low-grade inflammation, longCOVID, autoimmunity

Interventions

Group 1: Healthy volunteers with BMI 25 perform a three weeks/three month ad libitum ketogenic diet (KD). Group 2: Healthy subjects after COVID-19 infection perform a three weeks/three month ad libitu

Sponsors

LMU Klinikum München. Klinik für Anästhesiologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - written informed consent - age > 18 years Cohort 2 (additionally): - PCR-confirmed SARS-CoV-2 in the past (recovered) - Presence of one or more symptoms from the symptom complex of the Long-COVID syndrome Cohort 3 (additionally): - Presentation of one or more symptoms clinically considered to be associated with chronic inflammation and increased basal inflammatory T-cell function Cohort 4 according to Cohort 1

Exclusion criteria

Exclusion criteria: -Women who are pregnant or nursing -Application of glucocorticoids within the last 7 days -Serious metabolic or autoimmune disorders (such as diabetes) -Personal relationship with examiner. Cohort 3: -Women who are pregnant or nursing -Serious metabolic or autoimmune disorders (such as diabetes) -Personal relationship with examiner. Cohort 4: -Women who are pregnant or nursing -Application of glucocorticoids within the last 7 days -Personal relationship with examiner.

Design outcomes

Primary

MeasureTime frame
Changes of gene expression of pro-inflammatory cytokine IFNy in CD8+ T cells after three week KD.

Secondary

MeasureTime frame
Changes of additional pro and anti-inflammatory parameters: - mRNA expression profile in PBMC/whole blood: IL-2, IL-4, IL-6, IL-10, IL-17, IL-1beta, FOXP3, RORc, GATA3, T-bet, CTLA4 - protein secretion signature after TruCulture whole blood stimulation - Nextgene Sequencing for unknown pathways regulated by KD - flow cytometric analysis of T cell activation and composition subpopulations - analysis of mitochondrial respiration via flow cytometry (membrane potential, mitochondrial mass, ROS production), western-blot (protein levels of OXPHOS complexes, mTOR) - assessment of mitochondrial respiration and glycolysis as well as ATP production rate via Seahorse analysis - concentration of plasma ketone bodies via POCT - body weight and bioelectrical impedance analysis - comprehensive metabolomics, proteomics and transcriptomics using serum or immune cells - characterization of human microbiome (feces/urine) - analysis of amino acid pathways in urine samples (focus of tryptophan, phenylalanine) and bile metabolites in serum - assessment of health-related quality of life using WHOQOL-BREF/SF-36 questionnaire and Fatigue Assessment Scale - Analysis of the Disease Activity Score (DAS 28 CRP) - Analysis of the PASI score - Analysis of food-specific IgG/IgG4 Antibodies - Quantification of body height and weight and analysis of body composition using bioelectrical impedance analysis

Countries

Germany

Contacts

Public ContactSimon Hirschberger

LMU Klinikum München, Klinik für Anaesthesiologie

simon.hirschberger@med.uni-muenchen.de81377

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026