NCT04404413

Brief Summary

The objective of this study is to compare the body composition and physical performance effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance (Hand-grip strength, Counter movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in between both phases when they did not perform the scheduled activity, so as not to alter the experimental phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

10 days

First QC Date

May 19, 2020

Last Update Submit

May 21, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • Hand-grip strength

    Hand-grip strength test was performed as an indicator of overall strength.

    16 weeks

  • Counter movement jump (CMJ)

    In the CMJ test, the participants performed a maximum vertical jump starting from a standing position with arm swing not allowed.

    16 weeks

  • Wingate Anaerobic 30 s Cycling Test

    Wingate Anaerobic 30 s Cycling Test with a validated cycloergometer (Monark 894E, Vansbro, Sweden).

    16 weeks

  • Fat mass

    Body composition masses were estimated using validated equations. Carter's equation was used to estimate fat mass.

    16 weeks

  • Muscle mass

    Body composition masses were estimated using validated equations. Lee's equation to estimate muscle mass.

    16 weeks

  • Residual mass

    Body composition masses were estimated using validated equations. Residual mass was obtained from the difference between fat mass and muscle mass.

    16 weeks

  • Body Mass

    It was performed using a digital scale with 0,1kg accuracy (Tanita BC-545, Tokyo, Japan).

    16 weeks

Study Arms (1)

PARTICIPANTS

EXPERIMENTAL

A single-group crossover design was used to compare the effects of 2x8 weeks of high-intensity interval training without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance. There were two weeks in the middle of both phases in which they did not carry out programmed activity, in order not to alter the experimental phase.

Behavioral: Intensity interval training (HIIT)Behavioral: Intensity interval training (HIIT) + intermittent fasting

Interventions

2x8 weeks of high-intensity interval training (HIIT)

PARTICIPANTS

2x8 high-intensity interval training with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake).

PARTICIPANTS

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No muscular, ligamentous, bone, nerve or joint pathology incompatible with the training program.
  • Not to present cardiovascular or cardiorespiratory problems.
  • Physically active in the last 5 years, according to the American College of Sports Medicine (ACSM) definition.

You may not qualify if:

  • Following pharmacological treatment or supplement.
  • Performing other sports activities that may influence the study results during their participation in the study.
  • Not following training or diet program guidelines or attending scheduled training sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alejandro Martínez Rodriguez

San Vicent del Raspeig, Alicante, 03690, Spain

Location

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

FastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 27, 2020

Study Start

September 1, 2019

Primary Completion

September 11, 2019

Study Completion

March 1, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations