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Immunological and metabolic effects of dietary methionine reduction in healthy volunteers (MEDIATE)

Immunological and metabolic effects of dietary methionine reduction in healthy volunteers (MEDIATE) - MEDIATE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00032816
Enrollment
24
Registered
2023-10-31
Start date
2023-11-20
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Prevention, autophagy, fasting simulation by dietary methionine restriction

Interventions

Group 1: Following Visit 1, a 14-day dietary methionine restriction to 10 mg/kg bw/d is implemented in healthy subjects on the basis of a plant-based diet, with the exclusion of protein-rich foods in

Sponsors

Charité Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Men and women in a ratio of 1:1 - Body Mass Index 18.5 - 29.9 kg/m2 - Ability to provide informed consent - Existing health insurance to cover any necessary clarification and treatment of incidental findings.

Exclusion criteria

Exclusion criteria: - Diseases or functional disorders which, in the opinion of the study doctor preclude participation in the study - Severe, manifest and treatment-requiring diseases - Permanent use of prescription drugs (except hormonal contraception) - Vitamin B6, B12 and folic acid levels below the normal range - Homocysteinemia - Postoperative phases - Acute and chronic infections - Special diet for medical reasons - Taking food supplements - Food intolerances - Vegetarian or vegan diet - Pregnancy and breastfeeding - Smoker - Following a diet or weight reduction programme - Change in body weight of more than 2 kg in the previous month of the study - Habitual methionine intake < 20 mg/kg bw/d - Known medication, drug or alcohol abuse - Incapacity or other circumstances that do not allow the subject to fully understand the nature, meaning and implications of this study

Design outcomes

Primary

MeasureTime frame
Detection of autophagy activation by autophagic flux (LC3-II) and mTOR (p-S6 and p-4EBP1) by flow cytometry after 14 days of dietary methionine reduction (10 mg/kg bw/d)

Secondary

MeasureTime frame
- Change of Methionine concentration in plasma and urine measured by LC-MS mass spectroscopy - Change of body fat content, measured by air displacement plethysmography - Change of Office Blood pressure (mmHg), non-invasively measured (NIBP) - Change of pulse wave velocity (m/s), measured by PulsePen - Change of frequency of pro- and anti-inflammatory immune cells; immunophenotyping of PBMCs using flow cytometry - Changed immune cell function (cytokines, proliferation after in vitro stimulation of different PBMC populations) measured by flow cytometry - Changed metabolite patterns in plasma and urine, measured by non-targeted (H-NMR spectroscopy) and targeted metabolomics (LCMS) - Changed concentrations of inflammatory or anti-inflammatory circulating cytokines in blood plasma, measured by multiplex cytokine analysis - Changed expression of senescence markers in various immune cell populations, measured by flow cytometry - Changed expression profile of key methionine cycle genes measured by qPCR in specific immune cell types - Histone methylation patterns of key genes, assessed by DNA methylation patterns in specific immune cell types

Countries

Germany

Contacts

Public ContactSylvia Bähring

Charité - Universitätsmedizin Berlin, Experimental and Clinical Research Center (ECRC), Clinical Research Unit

sylvia.baehring@charite.de+49 30 450 540214

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026