NCT04000750

Brief Summary

The purpose is to examine the effects of time-restricted eating (TRE; consuming all calories within an 8-hour period each day) vs. normal eating (CON; consuming same kcals and protein as TRE, but during a 10-13 hr eating window each day) during 8 weeks of resistance exercise on body composition and muscle mass (whole muscle and single fiber), muscular performance, anabolic protein signaling, single muscle fiber characteristics, and the gut microbiome in well-trained young men and women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 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

June 24, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
Last Updated

February 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

June 25, 2019

Last Update Submit

February 8, 2023

Conditions

Keywords

HypertrophyIntermittent FastingTime Restricted EatingProtein SignalingAnabolic

Outcome Measures

Primary Outcomes (5)

  • Changes in Muscle Size - Lower Body

    via Ultrasound

    Pre, Mid (4 weeks), and Post (8 weeks)

  • Changes in Muscle Size - Upper Body

    via Ultrasound

    Pre, Mid (4 weeks), and Post (8 weeks)

  • Changes in Fiber Type-Specific Size

    Single muscle fiber analysis

    Pre and Post (week 8)

  • Changes in Body composition

    via BodPod

    Pre, Mid (4 weeks), and Post (8 weeks)

  • Acute Exercise Induced Fiber Type-Specific Anabolic Signaling (Total Concentration and Phosphorylation Status)

    Men only; assessed via single fiber Simple Western

    Day 1 of exercise training

Secondary Outcomes (11)

  • Changes in Maximal Strength

    Pre and Post (week 8)

  • Changes in Maximal Muscular Endurance

    Pre and Post (week 8)

  • Changes in Gut Microbiome

    Pre, Mid (week 2, 4, 6), and Post (week 8)

  • Changes in Fiber Type Composition

    Pre and Post (week 8)

  • Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status)

    Pre and Post (week 8)

  • +6 more secondary outcomes

Study Arms (2)

Time Restricted Eating (16:8)

EXPERIMENTAL

Participants will consume all calories within an 8 hour window each day.

Other: Time Restricted EatingOther: Resistance TrainingDietary Supplement: Whey Protein

Control

ACTIVE COMPARATOR

Participants will consume all calories within a \~12 hour window each day (4 separate meals + needed snacks).

Other: Normal FeedingOther: Resistance TrainingDietary Supplement: Whey Protein

Interventions

Diet will be tracked and reported every day to a qualified dietitian.

Time Restricted Eating (16:8)

Diet will be tracked and reported every day to a qualified dietitian.

Control

8 weeks of supervised and programmed whole body resistance training, performed 4x per week

ControlTime Restricted Eating (16:8)
Whey ProteinDIETARY_SUPPLEMENT

Consumed on all exercise days.

ControlTime Restricted Eating (16:8)

Eligibility Criteria

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

You may qualify if:

  • years old with \<25% (men) or \<30% (women) body fat
  • have experience in resistance exercise for the whole body and performed resistance exercise at least 3 times per week the last 12 months
  • be able to perform all necessary exercises with safe technique and no pain
  • be able to squat 1.5x (men) or 1x (women) body weight
  • be able to bench press 1.1x (men) or 0.55x (women) body weight
  • be on a non-specialized, mixed macronutrient diet
  • have a lifestyle which enables a reasonably consistent 7+ hours of sleep per night
  • be free of any current joint, musculoskeletal, and/or neuromuscular injuries

You may not qualify if:

  • have any known current illness, prohibitive muscular or neuromuscular problem, hypertension, cardiac, pulmonary, liver, kidney, insulin or any other metabolic disorders (e.g. Type I or Type II diabetes)
  • are lactose intolerant or unable to consume whey protein for any reason
  • are on any medications known to affect protein metabolism
  • have taken antibiotics in the last 6 months
  • cannot refrain from consuming any alcoholic beverages, nicotine, or marijuana (or derivative) for a period of 48 hours prior to data collection (pre and post testing)
  • consume alcohol \>2x per week
  • consume any analgesic or anti-inflammatory drug(s), prescription or non-prescription, chronically or within 48 hours of data collection
  • consume any recreational drug(s), prescription or non-prescription, legal or illegal, chronically or within 30 days of data collection
  • consume any caffeine or food within 12 hours of data collection
  • cannot refrain from physical exercise (outside of activities of daily living) outside of what is prescribed by the research team for the duration of the study
  • cannot refrain from using recovery methods such as electric stimulation, hot/cold therapy, massage, chiropractic, or personal air/water devices (Normatech, etc.)
  • have utilized any anabolic steroid, currently or in the past
  • cannot refrain from consumption of any supplementation (creatine, multivitamin, fish oil, protein powder, BCAA, pre-workouts, etc.) outside of what is provided
  • cannot refrain from consuming any supplemental pro or prebiotics or other items that intentionally alter the gut microbiome
  • fail to adhere to the nutritional guidelines or miss \>3 of the exercise sessions
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Sport Performance at California State University, Fullerton

Fullerton, California, 92831, United States

Location

MeSH Terms

Conditions

HypertrophyIntermittent Fasting

Interventions

Resistance TrainingWhey Proteins

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants will know their group. Training and Nutrition research team members will know the participants group. Data analysis team will be blinded to condition.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

June 24, 2019

Primary Completion

July 15, 2021

Study Completion

February 5, 2023

Last Updated

February 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations