Time-Restricted Eating and Muscle Hypertrophy

February 8, 2023 updated by: Andrew Galpin, California State University, Fullerton

The Influence of 16:8 Time-Restricted Eating on Resistance Exercise-Induced Skeletal Muscle Hypertrophy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary goal pertains to muscle hypertrophy (not fat loss), thus all participants will be placed in a 10% caloric surplus.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92831
        • Center for Sport Performance at California State University, Fullerton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-35 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

Exclusion Criteria:

  • 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
  • were recently pregnant, trying to become pregnant, or are currently breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Time Restricted Eating (16:8)
Participants will consume all calories within an 8 hour window each day.
Other: Time Restricted Eating
Diet will be tracked and reported every day to a qualified dietitian.
Other: Resistance Training
8 weeks of supervised and programmed whole body resistance training, performed 4x per week
Dietary supplement: Whey Protein
Consumed on all exercise days.
ACTIVE_COMPARATOR: Control
Participants will consume all calories within a ~12 hour window each day (4 separate meals + needed snacks).
Other: Resistance Training
8 weeks of supervised and programmed whole body resistance training, performed 4x per week
Dietary supplement: Whey Protein
Consumed on all exercise days.
Other: Normal Feeding
Diet will be tracked and reported every day to a qualified dietitian.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Muscle Size - Lower Body
Time Frame: Pre, Mid (4 weeks), and Post (8 weeks)
via Ultrasound
Pre, Mid (4 weeks), and Post (8 weeks)
Changes in Muscle Size - Upper Body
Time Frame: Pre, Mid (4 weeks), and Post (8 weeks)
via Ultrasound
Pre, Mid (4 weeks), and Post (8 weeks)
Changes in Fiber Type-Specific Size
Time Frame: Pre and Post (week 8)
Single muscle fiber analysis
Pre and Post (week 8)
Changes in Body composition
Time Frame: Pre, Mid (4 weeks), and Post (8 weeks)
via BodPod
Pre, Mid (4 weeks), and Post (8 weeks)
Acute Exercise Induced Fiber Type-Specific Anabolic Signaling (Total Concentration and Phosphorylation Status)
Time Frame: Day 1 of exercise training
Men only; assessed via single fiber Simple Western
Day 1 of exercise training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Maximal Strength
Time Frame: Pre and Post (week 8)
1RM on bench press, squat, and leg extension
Pre and Post (week 8)
Changes in Maximal Muscular Endurance
Time Frame: Pre and Post (week 8)
Maximal repetitions on bench press and leg press
Pre and Post (week 8)
Changes in Gut Microbiome
Time Frame: Pre, Mid (week 2, 4, 6), and Post (week 8)
via stool sample
Pre, Mid (week 2, 4, 6), and Post (week 8)
Changes in Fiber Type Composition
Time Frame: Pre and Post (week 8)
Single Fiber via SDS-PAGE
Pre and Post (week 8)
Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status)
Time Frame: Pre and Post (week 8)
via single fiber Simple Western
Pre and Post (week 8)
Changes in Mood
Time Frame: Weekly for duration of the intervention (8 weeks)
via Questionnaire
Weekly for duration of the intervention (8 weeks)
Changes in Enjoyment of Diet
Time Frame: Weekly for duration of the intervention (8 weeks)
via Questionnaire
Weekly for duration of the intervention (8 weeks)
Changes in Sleep (total and quality)
Time Frame: Weekly for duration of the intervention (8 weeks)
via Questionnaire
Weekly for duration of the intervention (8 weeks)
Changes in Menstrual Cycle
Time Frame: Pre, Mid (week 4), and post (week 8)
via Questionnaire; women only
Pre, Mid (week 4), and post (week 8)
Total Training Volume
Time Frame: After 8 weeks
After 8 weeks
Nutrient Intake
Time Frame: Daily, starting 7 days before the study and continuing for 8 additional weeks
Total Kcal and grams of protein, fat, and carbohydrates
Daily, starting 7 days before the study and continuing for 8 additional weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
California State University, Fullerton

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
San Francisco State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2019

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSP Fullerton

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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