NCT05482750

Brief Summary

It is well evidenced in the literature that fasting aerobic exercise generates a series of metabolic differences when compared to exercise performed in the fed state, including the use of fats predominantly as an energy source. Consequently, increases in adaptations to aerobic training, related to health and physical performance, are observed when sessions are performed in the fasted state. In relation to resistance training, the evidence is limited. There is a lack of data in the literature regarding the effects of fasting on resistance exercises and whether this practice may reflect in losses or improvements in morphological and neuromuscular adaptations related to resistance training. Thus, the aim of the present project is to compare the effects of resistance training performed in the fasted state compared to the fed state during 12 weeks on body composition and physical performance in young adults. Thirty-four eutrophic or overweight individuals, not engaged in regular resistance exercises, aged between 20 and 40 years, will be recruited. They will be put on a standard customized diet and will perform 2 weekly sessions of resistance exercise after overnight fasting (10 to 12 hours) or in the fed state, for 12 weeks. Before, in the middle and after this period, evaluations of body composition, muscle thickness and quality, maximum dynamic strength and maximum power will be analyzed. Comparisons will be performed using Generalized Estimating Equations (GEE), adopting the factors group (2 stratifications) and time (3 stratifications). All results will be expressed as mean and standard deviation and the accepted significance level will be 5%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

July 25, 2022

Last Update Submit

May 8, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Body mass

    Body mass will be measured using a scale (Urano, Canoas, Brazil).

    1 minute

  • Lean body mass

    Lean body mass will be determined using the dual energy X-ray absorption (DEXA) method, using a densitometry machine (Hologic GE, Bedford, USA).

    15 minutes

  • Fat body mass

    Fat body mass will be determined using the dual energy X-ray absorption (DEXA) method, using a densitometry machine (Hologic GE, Bedford, USA).

    15 minutes

  • Muscle thickness

    Muscle thickness will be evaluated through ultrasound (Nemio XG, Toshiba, Japan).

    30 minutes

  • Muscle quality

    Muscle quality will be evaluated through echo intensity of the quadriceps through ultrasound (Nemio XG, Toshiba, Japan).

    30 minutes

  • Maximum dynamic strength

    Maximum dynamic strength will be assessed using the 1 repetition maximum (1RM) test for bench press and knee extension exercises.

    30 minutes

  • Maximum power

    The maximum power and the medium power will be evaluated in the bench press and knee extension exercises considering a load of 30 and 70% of 1RM.

    30 minutes

Study Arms (2)

Resistance training in the fasted state

EXPERIMENTAL

Subjects will maintain the standard diet and will perform resistance exercise sessions after overnight fasting (10 to 12 hours). Over the 12 weeks of intervention, participants will perform two sessions a week of resistance exercises.

Other: Resistance training in the fasted state

Resistance training in the fed state

ACTIVE COMPARATOR

Subjects will maintain the standard diet and will perform resistance exercise sessions in the fed state, between 1 and 2 hours after consuming a carbohydrate-containing meal. Over the 12 weeks of intervention, participants will perform two sessions a week of resistance exercises.

Other: Resistance training in the fed state

Interventions

On the first day of evaluations, the subjects will perform the basal metabolic rate (BMR) analysis, as well as familiarization with the neuromuscular tests. After the preliminary tests, the volunteers will perform the pre-intervention procedures. Assessments of body composition, muscle thickness and quality, maximum dynamic strength and maximum power will be performed. In addition, instruments related to dietary control and physical activity level will be applied. Subsequently, in a randomized manner, participants will be allocated to one of two different interventions. During the intervention (8 weeks), the adherence to the standard diet will be verified, as well as body composition, muscle thickness and quality, maximum dynamic strength and maximum power will be reassessed. After the 12 weeks of intervention, the volunteers will perform the evaluations referring to the post-intervention moment, following the same steps of the pre-intervention collections.

Also known as: Fasting, Strength training
Resistance training in the fasted state

On the first day of evaluations, the subjects will perform the basal metabolic rate (BMR) analysis, as well as familiarization with the neuromuscular tests. After the preliminary tests, the volunteers will perform the pre-intervention procedures. Assessments of body composition, muscle thickness and quality, maximum dynamic strength and maximum power will be performed. In addition, instruments related to dietary control and physical activity level will be applied. Subsequently, in a randomized manner, participants will be allocated to one of two different interventions. During the intervention (8 weeks), the adherence to the standard diet will be verified, as well as body composition, muscle thickness and quality, maximum dynamic strength and maximum power will be reassessed. After the 12 weeks of intervention, the volunteers will perform the evaluations referring to the post-intervention moment, following the same steps of the pre-intervention collections.

Also known as: Feeding, Strength training
Resistance training in the fed state

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women;
  • Aged between 19 and 40 years;
  • Body mass index (BMI) between 18 and 29.9 kg/m²;
  • Not engaged in regular strength physical exercise (\>1 weekly session) for the last 3 months.

You may not qualify if:

  • Smokers;
  • Use of medications and/or supplements that may influence the outcomes evaluated;
  • Individuals who have a chronic disease that may prevent physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Educação Física, Fisioterapia e Dança - UFRGS

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

MeSH Terms

Conditions

FastingMotor Activity

Interventions

Resistance TrainingAngptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2022

First Posted

August 1, 2022

Study Start

May 23, 2022

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations