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Time-Restricted Eating and Muscle Hypertrophy

Primary Purpose

Muscle Hypertrophy, Healthy and Well-Trained Men and Women

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time Restricted Eating
Normal Feeding
Resistance Training
Whey Protein
Sponsored by
California State University, Fullerton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Hypertrophy focused on measuring Hypertrophy, Intermittent Fasting, Time Restricted Eating, Protein Signaling, Anabolic

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Sport Performance at California State University, Fullerton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Time Restricted Eating (16:8)

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in Muscle Size - Lower Body
via Ultrasound
Changes in Muscle Size - Upper Body
via Ultrasound
Changes in Fiber Type-Specific Size
Single muscle fiber analysis
Changes in Body composition
via BodPod
Acute Exercise Induced Fiber Type-Specific Anabolic Signaling (Total Concentration and Phosphorylation Status)
Men only; assessed via single fiber Simple Western

Secondary Outcome Measures

Changes in Maximal Strength
1RM on bench press, squat, and leg extension
Changes in Maximal Muscular Endurance
Maximal repetitions on bench press and leg press
Changes in Gut Microbiome
via stool sample
Changes in Fiber Type Composition
Single Fiber via SDS-PAGE
Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status)
via single fiber Simple Western
Changes in Mood
via Questionnaire
Changes in Enjoyment of Diet
via Questionnaire
Changes in Sleep (total and quality)
via Questionnaire
Changes in Menstrual Cycle
via Questionnaire; women only
Total Training Volume
Nutrient Intake
Total Kcal and grams of protein, fat, and carbohydrates

Full Information

First Posted
June 25, 2019
Last Updated
February 8, 2023
Sponsor
California State University, Fullerton
Collaborators
San Francisco State University
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1. Study Identification

Unique Protocol Identification Number
NCT04000750
Brief Title
Time-Restricted Eating and Muscle Hypertrophy
Official Title
The Influence of 16:8 Time-Restricted Eating on Resistance Exercise-Induced Skeletal Muscle Hypertrophy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
February 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California State University, Fullerton
Collaborators
San Francisco State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Hypertrophy, Healthy and Well-Trained Men and Women
Keywords
Hypertrophy, Intermittent Fasting, Time Restricted Eating, Protein Signaling, Anabolic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will know their group. Training and Nutrition research team members will know the participants group. Data analysis team will be blinded to condition.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time Restricted Eating (16:8)
Arm Type
Experimental
Arm Description
Participants will consume all calories within an 8 hour window each day.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will consume all calories within a ~12 hour window each day (4 separate meals + needed snacks).
Intervention Type
Other
Intervention Name(s)
Time Restricted Eating
Intervention Description
Diet will be tracked and reported every day to a qualified dietitian.
Intervention Type
Other
Intervention Name(s)
Normal Feeding
Intervention Description
Diet will be tracked and reported every day to a qualified dietitian.
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
8 weeks of supervised and programmed whole body resistance training, performed 4x per week
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein
Intervention Description
Consumed on all exercise days.
Primary Outcome Measure Information:
Title
Changes in Muscle Size - Lower Body
Description
via Ultrasound
Time Frame
Pre, Mid (4 weeks), and Post (8 weeks)
Title
Changes in Muscle Size - Upper Body
Description
via Ultrasound
Time Frame
Pre, Mid (4 weeks), and Post (8 weeks)
Title
Changes in Fiber Type-Specific Size
Description
Single muscle fiber analysis
Time Frame
Pre and Post (week 8)
Title
Changes in Body composition
Description
via BodPod
Time Frame
Pre, Mid (4 weeks), and Post (8 weeks)
Title
Acute Exercise Induced Fiber Type-Specific Anabolic Signaling (Total Concentration and Phosphorylation Status)
Description
Men only; assessed via single fiber Simple Western
Time Frame
Day 1 of exercise training
Secondary Outcome Measure Information:
Title
Changes in Maximal Strength
Description
1RM on bench press, squat, and leg extension
Time Frame
Pre and Post (week 8)
Title
Changes in Maximal Muscular Endurance
Description
Maximal repetitions on bench press and leg press
Time Frame
Pre and Post (week 8)
Title
Changes in Gut Microbiome
Description
via stool sample
Time Frame
Pre, Mid (week 2, 4, 6), and Post (week 8)
Title
Changes in Fiber Type Composition
Description
Single Fiber via SDS-PAGE
Time Frame
Pre and Post (week 8)
Title
Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status)
Description
via single fiber Simple Western
Time Frame
Pre and Post (week 8)
Title
Changes in Mood
Description
via Questionnaire
Time Frame
Weekly for duration of the intervention (8 weeks)
Title
Changes in Enjoyment of Diet
Description
via Questionnaire
Time Frame
Weekly for duration of the intervention (8 weeks)
Title
Changes in Sleep (total and quality)
Description
via Questionnaire
Time Frame
Weekly for duration of the intervention (8 weeks)
Title
Changes in Menstrual Cycle
Description
via Questionnaire; women only
Time Frame
Pre, Mid (week 4), and post (week 8)
Title
Total Training Volume
Time Frame
After 8 weeks
Title
Nutrient Intake
Description
Total Kcal and grams of protein, fat, and carbohydrates
Time Frame
Daily, starting 7 days before the study and continuing for 8 additional weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Center for Sport Performance at California State University, Fullerton
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Time-Restricted Eating and Muscle Hypertrophy

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