NCT06737224

Brief Summary

Many individuals engage in fasting for its purported health benefits but the effects of fasting on immune cell and whole body metabolism are not well understood in humans. Moreover, how exercising during a prolonged fast impacts immunometabolic outcomes is unclear. This study will determine how a 2 day fast - performed with or without daily exercise - impacts immune cell bioenergetics, immune cell function, and whole-body glycemic control in healthy active individuals.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

October 8, 2024

Last Update Submit

March 4, 2025

Conditions

Keywords

ExerciseImmunometabolismGlycemic control

Outcome Measures

Primary Outcomes (1)

  • Monocyte mitochondrial respiration

    Mitochondrial respiration will be measured in primary human monocytes using high resolution respirometry before and after a 48-hour fast performed with or without exercise.

    Baseline and 48 hours

Secondary Outcomes (11)

  • Alteration in immune cell functions

    Baseline and 48 hours

  • Change in glucose tolerance

    Baseline, after 48 hours of fasting, and 24 hours after breaking the fast in free-living condition)

  • Blood pressure

    Baseline, 24 hours into the fast, and at the end of the fast (48 hours)

  • Rate and level of ketosis

    Baseline, 24 hours and 48 hours during fasting

  • Compensatory movement behaviour

    During and 48 hours after the fast

  • +6 more secondary outcomes

Study Arms (2)

Fasting + Exercise (FAST+EX): fasting + exercise condition

EXPERIMENTAL

48-hour fast with 60 minutes of cycling on the first and second day of the fast.

Other: Fasting + Exercise (FAST+EX): fasting + exercise condition

Fasting only (FAST): Non-exercise fasting condition

EXPERIMENTAL

48-hour fast with no structured exercise on fasting days.

Other: Fasting only (FAST): Non-exercise fasting condition

Interventions

Participants will complete a 48-hour fast. One hour of exercise will be performed on each morning of the fast.

Fasting + Exercise (FAST+EX): fasting + exercise condition

Participant will complete a 48-hour fast. No structured exercise will be performed during each of the fasting days.

Fasting only (FAST): Non-exercise fasting condition

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 19 and 35 years.
  • Physically active (engaging in ≥150 minutes of weekly moderate to vigorous physical activity).

You may not qualify if:

  • History of cardiometabolic diseases or inflammatory diseases (e.g., chronic obstructive pulmonary disease (COPD), rheumatoid arthritis, cardiovascular disease).
  • Individuals currently following a ketogenic diet, low-calorie diet, periodic fasting regimen, or consuming ketogenic supplements (e.g., exogenous ketone drinks).
  • Cigarette/vaping smoking.
  • Physical limitation that will impair the ability of the participant to perform exercise.
  • Individuals having a body mass index (BMI) over 30 kg/m2.
  • Cancer diagnosis in the past 5 years.
  • Taking anti-inflammatory drugs (e.g., ibuprofen, aspirin, naproxen).
  • Being unable to read or communicate in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Okanagan Campus

Kelowna, British Columbia, V1V1V7, Canada

RECRUITING

MeSH Terms

Conditions

FastingMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jonathan Little Principal Investigator, Professor Little, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized crossover, within-subject, repeated measures
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2024

First Posted

December 17, 2024

Study Start

January 10, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to ensure the privacy and confidentiality of participants, in accordance with ethical guidelines and data protection regulations. Additionally, this was not included in the informed consent, which did not cover data sharing or address potential risks of re-identification.

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