NCT04842864

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 also demonstrated that autophagy declines with age in these simpler experimental models. However, human studies are lacking. Our study seeks to determine whether fasting, a robust stimulus of autophagy, upregulates autophagy in humans, and whether autophagy is reduced in healthy older people compared to healthy younger individuals.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

April 6, 2021

Last Update Submit

August 23, 2022

Conditions

FastingAutophagyAging WellKetosis, Metabolic

Outcome Measures

Primary Outcomes (1)

  • Autophagy flux

    The turnover rate of the autophagosome marker LC3-II will be assessed. LC3-II flux will be performed in freshly isolated fat tissues and in PBMCs at various timepoints. Freshly collected fat tissue explants and PBMCs will be incubated in dishes with high-glucose culture medium (DMEM) in the presence or absence of lysosomal inhibitors (Lys Inh), leupeptin (200uM) and ammonium chloride (20uM) at 37°C, 5% CO2 for 4 hours. Fat explants and scraped PMBC pellets will then be homogenized in a buffer containing protease and phosphatase inhibitors and subjected to immunoblotting for LC3. Autophagy flux will be determined by subtracting the densitometric value of LC3-II in Lys Inh-untreated samples from the Lys Inh-treated samples.

    23 hours

Secondary Outcomes (1)

  • Level of ketone bodies

    23 hours

Study Arms (2)

Young

EXPERIMENTAL

10 healthy men and women 18-35 yo.

Behavioral: Fasting

Older adults

ACTIVE COMPARATOR

10 healthy men and women 65-85 yo

Behavioral: Fasting

Interventions

FastingBEHAVIORAL

23 hours fasting

Older adultsYoung

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women 18-35 years of age
  • Healthy men and women 65-85 years of age

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

FastingKetosis

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jill Crandall, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Nir Barzilai, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Rajat Singh, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 13, 2021

Study Start

November 19, 2021

Primary Completion

May 31, 2022

Study Completion

February 1, 2023

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)