An Exploratory Clinical Study on Autophagy During Fasting

NCT04739852 | Unknown DMC

• 1 other identifier: Autophagy Fasting
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Autophagy is considered one of the key molecular mechanisms for the broad preventive and therapeutic effects of periodic fasting. While it is generally known that fasting induces autophagy, there are no human studies that focus on the size and temporal kinetics of autophagy and its association with fasting specific signaling pathways. The kinetics of autophagy in patients with chronic diseases will now be compared with the kinetics of autophagy in healthy subjects, who both fast according to the same scheme; and further changes in metabolic and inflammatory parameters will be investigated.

Conditions

Arthritis, Rheumatoid; Syndrome, Metabolic; Healthy

Keywords

Fasting; Autophagy

Outcome Measures

Primary Outcomes (2)

• Exploratory Proteomics of Autophagy Processes I

  \- Change in protein levels of autophagy biomarkers (LC3II \& p62) of isolated PBMCs (peripheral blood mononuclear cells) by Western Blotting, change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

  change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

• Exploratory Proteomics of Autophagy Processes II

  \- Change in protein levels and protein phosphorylation by untargeted mass spectrometry-based proteomics and phosphoproteomics of isolated PBMCs (peripheral blood mononuclear cells), change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

  change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

Secondary Outcomes (39)

• Muscle mass

  change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

• Body fat

  change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

• Resting blood pressure

  change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

• Cutaneous carotenoid level (CCL)

  change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

• Heart rate

  change from baseline over 5 fasting days, to day 3 refeeding and to 7 days follow up

Other Outcomes (1)

• Final questionnaire to record tolerability of fasting and nutrition, adverse effects

  After 6 weeks

Study Arms (3)

Healthy Participants

ACTIVE COMPARATOR

Healthy participants

Other: Fasting

Metabolic Syndrome

ACTIVE COMPARATOR

Participants with diagnosed metabolic syndrome

Other: Fasting

Rheumatoid Arthritis

ACTIVE COMPARATOR

Participants with diagnosed rheumatoid arthritis

Other: Fasting

Interventions

Fasting OTHER

Patients undergo a 5-10 day fasting period with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al.

Healthy Participants; Metabolic Syndrome; Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the following diagnoses: rheumatoid arthritis, metabolic syndrome OR healthy volunteer
• Beginning (first 24h) inpatient treatment or hospital stay at Immanuel Hospital Berlin, Department of Naturopathy OR healthy volunteer
• Present written declaration of consent

You may not qualify if:

• Insufficient linguistic communication
• Dementia or other cognitive disorder
• Pregnancy or lactation
• Simultaneous participation in another clinical trial

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Bonn AöR: collaborator

Study Sites (1)

Hochschulambulanz für Naturheilkunde der Charité-Universitätsmedizin Berlin am Immanuel-Krankenhaus

Berlin, 14109, Germany

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Metabolic Syndrome; Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Study Officials

• Andreas Michalsen, Prof. Dr.

  Charite - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

• Nils Gassen, Dr.

  Department of Psychiatry and Psychotherapy University Bonn, Clinical Centre

  STUDY DIRECTOR

Central Study Contacts

Nadine Sylvester

CONTACT

+4930 80505 734; nadine.sylvester@immanuelalbertinen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: 3 groups of different inclusion criteria (healthy, metabolic syndrome or rheumatoid arthritis) undergoing the same intervention

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: February 5, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)