Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Time-Restricted Eating and Muscle Hypertrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000750
Recruitment Status : Suspended (COVID-19)
First Posted : June 27, 2019
Last Update Posted : January 27, 2021
Sponsor:
Collaborator:
San Francisco State University
Information provided by (Responsible Party):
Andrew Galpin, California State University, Fullerton

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.

Condition or disease Intervention/treatment Phase
Muscle Hypertrophy Healthy and Well-Trained Men and Women Other: Time Restricted Eating Other: Normal Feeding Other: Resistance Training Dietary Supplement: Whey Protein Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Other
Official Title: The Influence of 16:8 Time-Restricted Eating on Resistance Exercise-Induced Skeletal Muscle Hypertrophy
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
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: Normal Feeding
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.




Primary Outcome Measures :
  1. Changes in Muscle Size - Lower Body [ Time Frame: Pre, Mid (4 weeks), and Post (8 weeks) ]
    via Ultrasound

  2. Changes in Muscle Size - Upper Body [ Time Frame: Pre, Mid (4 weeks), and Post (8 weeks) ]
    via Ultrasound

  3. Changes in Fiber Type-Specific Size [ Time Frame: Pre and Post (week 8) ]
    Single muscle fiber analysis

  4. Changes in Body composition [ Time Frame: Pre, Mid (4 weeks), and Post (8 weeks) ]
    via BodPod

  5. 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


Secondary Outcome Measures :
  1. Changes in Maximal Strength [ Time Frame: Pre and Post (week 8) ]
    1RM on bench press, squat, and leg extension

  2. Changes in Maximal Muscular Endurance [ Time Frame: Pre and Post (week 8) ]
    Maximal repetitions on bench press and leg press

  3. Changes in Gut Microbiome [ Time Frame: Pre, Mid (week 2, 4, 6), and Post (week 8) ]
    via stool sample

  4. Changes in Fiber Type Composition [ Time Frame: Pre and Post (week 8) ]
    Single Fiber via SDS-PAGE

  5. 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

  6. Changes in Mood [ Time Frame: Weekly for duration of the intervention (8 weeks) ]
    via Questionnaire

  7. Changes in Enjoyment of Diet [ Time Frame: Weekly for duration of the intervention (8 weeks) ]
    via Questionnaire

  8. Changes in Sleep (total and quality) [ Time Frame: Weekly for duration of the intervention (8 weeks) ]
    via Questionnaire

  9. Changes in Menstrual Cycle [ Time Frame: Pre, Mid (week 4), and post (week 8) ]
    via Questionnaire; women only

  10. Total Training Volume [ Time Frame: After 8 weeks ]
  11. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000750


Locations
Layout table for location information
United States, California
Center for Sport Performance at California State University, Fullerton
Fullerton, California, United States, 92831
Sponsors and Collaborators
California State University, Fullerton
San Francisco State University
Layout table for additonal information
Responsible Party: Andrew Galpin, Associate Professor, California State University, Fullerton
ClinicalTrials.gov Identifier: NCT04000750    
Other Study ID Numbers: CSP Fullerton
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Galpin, California State University, Fullerton:
Hypertrophy
Intermittent Fasting
Time Restricted Eating
Protein Signaling
Anabolic
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertrophy
Pathological Conditions, Anatomical