NCT04756635

Brief Summary

The therapeutic use of caloric restriction and intermittent fasting (IF) protocols improves life span and health related quality of life. The effects of fasting protocols on athletic performance and training adaptations have been primarily studied in athletes undergoing the Ramadan IF protocol or in athletes willing to decrease body fat, while maintaining or increasing lean body mass. Data from these studies are somewhat conflicting and unclear. Moreover, the effects of IF on muscular strength, as well as in aerobic and anaerobic capacity remain largely unknown. Anecdotal evidence from experienced participants in strength, power and endurance training or sports, indicates an increased ability to acutely display higher levels of work capacity in the fasted vs. fed state. The goal of this project is to determine the effects of 4 wks of IF on neuromuscular performance, aerobic and anaerobic capacity of well-trained young adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 22, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

2.9 years

First QC Date

February 12, 2021

Last Update Submit

July 25, 2022

Conditions

Keywords

Intermittent fastingneuromuscular performanceaerobic capacityanaerobic capacity

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Performance at 4 weeks

    Neuromuscular performance, aerobic and anaerobic capacity

    4weeks (experiemental) + 4weeks (control)

Secondary Outcomes (1)

  • Change from Baseline Body Composition at 4 weeks

    4weeks (experiemental) + 4weeks (control)

Study Arms (2)

Experimental Group

EXPERIMENTAL

Measures taken before and after the defined IF periods. Two groups of participants will be included in this project: 1) resistance trained group (tested for neuromuscular function, anaerobic capacity and body composition); 2) endurance trained group (tested for aerobic and anaerobic capacity and body composition). Experimental condition: pre- and post-4 weeks of IF. Measurements will be taken during the morning period (between 07:00 and 11:00 am) in the fasted state. Neuromuscular function and anaerobic capacity will be assessed on separate days (with at least a 48- hour interval) to ensure full recovery.

Other: Experimental Group

Control Group

OTHER

Participants of each group serving as their own controls. Control condition: pre- and post4 weeks of normal diet. Measurements will be taken during the morning period (between 07:00 and 11:00 am) in the fasted state. Neuromuscular function and anaerobic capacity will be assessed on separate days (with at least a 48-hour interval) to ensure full recovery.

Other: Experimental Group

Interventions

This 3-year project will include two groups of participants: 1) young men accustomed to resistance training (study #1) and 2) young men accustomed to endurance training (study #2). Inclusion will be limited to healthy participants (i.e. nonsmokers, normotensive with systolic and diastolic values \<135/85 mmHg, non-obese, non-medicated, and free of any known disease as assessed by medical history) (Pickering, Hall et al. 2005). Month 1-3 will focus on literature review and month 4 to 8 will address experimental settings preparation and selection of participants to include in each study. Testing and data collection will be scheduled for months 9-14 and 13-18 (study # 1 and 2 related testing, respectively). Data processing, analysis and presentation will occur from month 21 to 33. All participants will read and sign an informed consent document with the description of the testing procedures. The Faculty's ethical committee will be asked to approve this document before testing.

Also known as: Aerobic capacity, Anaerobic capacity, Neuromuscular performance
Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joana Correia

Lisbon, 1499-002, Portugal

RECRUITING

Related Publications (1)

  • Correia JM, Pezarat-Correia P, Minderico C, Infante J, Mendonca GV. Effects of Time-Restricted Eating on Aerobic Capacity, Body Composition, and Markers of Metabolic Health in Healthy Male Recreational Runners: A Randomized Crossover Trial. J Acad Nutr Diet. 2024 Aug;124(8):1041-1050. doi: 10.1016/j.jand.2024.01.005. Epub 2024 Jan 17.

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1Intermittent Fasting

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesFastingFeeding BehaviorBehavior

Study Officials

  • Joana M. Correia, Master

    Faculdade de Motricidade Humana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joana M. Correia, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 16, 2021

Study Start

May 22, 2018

Primary Completion

April 12, 2021

Study Completion

February 5, 2023

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Public articles with no reference to participants

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
The data will be stored in an SPSS and excel database, on the server of the Faculty of Human Motricity assigned to the Motor Behavior Laboratory. Paper-based documents will be destroyed after the data processing matrix is built.
Access Criteria
Public articles with no reference to participants

Locations