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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04000750
Other study ID # CSP Fullerton
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 24, 2019
Est. completion date February 5, 2023

Study information

Verified date February 2023
Source California State University, Fullerton
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 5, 2023
Est. primary completion date July 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Time Restricted Eating
Diet will be tracked and reported every day to a qualified dietitian.
Normal Feeding
Diet will be tracked and reported every day to a qualified dietitian.
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.

Locations

Country Name City State
United States Center for Sport Performance at California State University, Fullerton Fullerton California

Sponsors (2)

Lead Sponsor Collaborator
California State University, Fullerton San Francisco State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Muscle Size - Lower Body via Ultrasound Pre, Mid (4 weeks), and Post (8 weeks)
Primary Changes in Muscle Size - Upper Body via Ultrasound Pre, Mid (4 weeks), and Post (8 weeks)
Primary Changes in Fiber Type-Specific Size Single muscle fiber analysis Pre and Post (week 8)
Primary Changes in Body composition via BodPod Pre, Mid (4 weeks), and Post (8 weeks)
Primary 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 Changes in Maximal Strength 1RM on bench press, squat, and leg extension Pre and Post (week 8)
Secondary Changes in Maximal Muscular Endurance Maximal repetitions on bench press and leg press Pre and Post (week 8)
Secondary Changes in Gut Microbiome via stool sample Pre, Mid (week 2, 4, 6), and Post (week 8)
Secondary Changes in Fiber Type Composition Single Fiber via SDS-PAGE Pre and Post (week 8)
Secondary Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status) via single fiber Simple Western Pre and Post (week 8)
Secondary Changes in Mood via Questionnaire Weekly for duration of the intervention (8 weeks)
Secondary Changes in Enjoyment of Diet via Questionnaire Weekly for duration of the intervention (8 weeks)
Secondary Changes in Sleep (total and quality) via Questionnaire Weekly for duration of the intervention (8 weeks)
Secondary Changes in Menstrual Cycle via Questionnaire; women only Pre, Mid (week 4), and post (week 8)
Secondary Total Training Volume After 8 weeks
Secondary Nutrient Intake Total Kcal and grams of protein, fat, and carbohydrates Daily, starting 7 days before the study and continuing for 8 additional weeks
See also
  Status Clinical Trial Phase
Completed NCT03993483 - Upper Versus Lower Limb Responses to Higher Versus Lower Load Resistance Training in Young Men N/A
Completed NCT03991117 - Lower and Higher Load Resistance Exercise Protocols: Acute Muscle Activation and Skeletal Muscle Hypertrophy N/A