- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04000750
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
20
Phase
- 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
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California
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Fullerton, California, United States, 92831
- Center for Sport Performance at California State University, Fullerton
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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
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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Time Restricted Eating (16:8)
Participants will consume all calories within an 8 hour window each day.
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Diet will be tracked and reported every day to a qualified dietitian.
8 weeks of supervised and programmed whole body resistance training, performed 4x per week
Consumed on all exercise days.
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ACTIVE_COMPARATOR: Control
Participants will consume all calories within a ~12 hour window each day (4 separate meals + needed snacks).
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8 weeks of supervised and programmed whole body resistance training, performed 4x per week
Consumed on all exercise days.
Diet will be tracked and reported every day to a qualified dietitian.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Muscle Size - Lower Body
Time Frame: Pre, Mid (4 weeks), and Post (8 weeks)
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via Ultrasound
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Pre, Mid (4 weeks), and Post (8 weeks)
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Changes in Muscle Size - Upper Body
Time Frame: Pre, Mid (4 weeks), and Post (8 weeks)
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via Ultrasound
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Pre, Mid (4 weeks), and Post (8 weeks)
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Changes in Fiber Type-Specific Size
Time Frame: Pre and Post (week 8)
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Single muscle fiber analysis
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Pre and Post (week 8)
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Changes in Body composition
Time Frame: Pre, Mid (4 weeks), and Post (8 weeks)
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via BodPod
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Pre, Mid (4 weeks), and Post (8 weeks)
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Acute Exercise Induced Fiber Type-Specific Anabolic Signaling (Total Concentration and Phosphorylation Status)
Time Frame: Day 1 of exercise training
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Men only; assessed via single fiber Simple Western
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Day 1 of exercise training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Maximal Strength
Time Frame: Pre and Post (week 8)
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1RM on bench press, squat, and leg extension
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Pre and Post (week 8)
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Changes in Maximal Muscular Endurance
Time Frame: Pre and Post (week 8)
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Maximal repetitions on bench press and leg press
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Pre and Post (week 8)
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Changes in Gut Microbiome
Time Frame: Pre, Mid (week 2, 4, 6), and Post (week 8)
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via stool sample
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Pre, Mid (week 2, 4, 6), and Post (week 8)
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Changes in Fiber Type Composition
Time Frame: Pre and Post (week 8)
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Single Fiber via SDS-PAGE
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Pre and Post (week 8)
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Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status)
Time Frame: Pre and Post (week 8)
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via single fiber Simple Western
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Pre and Post (week 8)
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Changes in Mood
Time Frame: Weekly for duration of the intervention (8 weeks)
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via Questionnaire
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Weekly for duration of the intervention (8 weeks)
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Changes in Enjoyment of Diet
Time Frame: Weekly for duration of the intervention (8 weeks)
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via Questionnaire
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Weekly for duration of the intervention (8 weeks)
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Changes in Sleep (total and quality)
Time Frame: Weekly for duration of the intervention (8 weeks)
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via Questionnaire
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Weekly for duration of the intervention (8 weeks)
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Changes in Menstrual Cycle
Time Frame: Pre, Mid (week 4), and post (week 8)
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via Questionnaire; women only
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Pre, Mid (week 4), and post (week 8)
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Total Training Volume
Time Frame: After 8 weeks
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After 8 weeks
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Nutrient Intake
Time Frame: Daily, starting 7 days before the study and continuing for 8 additional weeks
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Total Kcal and grams of protein, fat, and carbohydrates
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Daily, starting 7 days before the study and continuing for 8 additional weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
June 24, 2019
Primary Completion (ACTUAL)
July 15, 2021
Study Completion (ACTUAL)
February 5, 2023
Study Registration Dates
First Submitted
June 25, 2019
First Submitted That Met QC Criteria
June 26, 2019
First Posted (ACTUAL)
June 27, 2019
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 8, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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