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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04404413
Other study ID # CE061811
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date March 1, 2020

Study information

Verified date May 2020
Source University of Alicante
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date March 1, 2020
Est. primary completion date September 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

1. No muscular, ligamentous, bone, nerve or joint pathology incompatible with the training program.

2. Not to present cardiovascular or cardiorespiratory problems.

3. Physically active in the last 5 years, according to the American College of Sports Medicine (ACSM) definition.

Exclusion Criteria:

1. Following pharmacological treatment or supplement.

2. Performing other sports activities that may influence the study results during their participation in the study.

3. Not following training or diet program guidelines or attending scheduled training sessions.

Study Design


Intervention

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

Locations

Country Name City State
Spain Alejandro Martínez Rodriguez San Vicente Del Raspeig Alicante

Sponsors (2)

Lead Sponsor Collaborator
University of Alicante Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hand-grip strength Hand-grip strength test was performed as an indicator of overall strength. 16 weeks
Primary 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
Primary Wingate Anaerobic 30 s Cycling Test Wingate Anaerobic 30 s Cycling Test with a validated cycloergometer (Monark 894E, Vansbro, Sweden). 16 weeks
Primary Fat mass Body composition masses were estimated using validated equations. Carter's equation was used to estimate fat mass. 16 weeks
Primary Muscle mass Body composition masses were estimated using validated equations. Lee's equation to estimate muscle mass. 16 weeks
Primary 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
Primary Body Mass It was performed using a digital scale with 0,1kg accuracy (Tanita BC-545, Tokyo, Japan). 16 weeks
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