Status:
WITHDRAWN
Time Course for Fasting-induced Autophagy in Humans
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Glenn Foundation for Medical Research
Conditions:
Fasting
Autophagy
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Autophagy, which involves the degradation of aged or damaged cellular components, has been shown to extend healthspan and lifespan in multiple organisms, including flies, worms, and mice. Research has...
Detailed Description
Autophagy is a cellular quality control pathway that degrades aged or damaged organelles and protein aggregates within lysosomes. By doing so, autophagy provides an alternate source of energy for cell...
Eligibility Criteria
Inclusion
- Healthy men and women 18-35 years of age
- Healthy men and women 65-85 years of age
Exclusion
- Serious acute/chronic illness (e.g., active cancer, inflammatory states, RA, SLE, or a CVD event within past 6 months)
- Diabetes or pre-diabetes with an A1c \>6.0%
- Pregnancy
- BMI \>30 kg/m2 or \<20 kg/m2
- eGFR \<45 ml/min
- ALT \>3x ULN
- Hct \<35 or Hb \<10
- Exclusionary meds: calcium channel blockers, anticonvulsants or other drugs shown to affect autophagy (see table below)
- Food allergy or known food intolerance
- Active Smoking (\>1 cigarette or cigar per week)
- Use of recreational drugs (opioids, cocaine, marijuana, etc.) in past month
- Use of alcohol on the day prior to and the day of study
- Shift workers or other dysregulated sleep pattern (habitual use of sleep medications, jet lag, etc.)
- Strenuous exercise within 3 days prior to study visit 2
- Any condition the investigator believes would impair the ability to interpret targeted outcomes
Key Trial Info
Start Date :
November 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04842864
Start Date
November 19 2021
End Date
February 1 2023
Last Update
August 26 2022
Active Locations (1)
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1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461