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Muscle HypertrophyNCT04000750

Time-Restricted Eating and Muscle Hypertrophy

A study testing Time Restricted Eating, Normal Feeding and Resistance Training in people with Muscle Hypertrophy and Healthy and Well-Trained Men and Women, run by California State University, Fullerton at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
What is being tested?
Time Restricted Eating, Normal Feeding and Resistance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
24 Jun 2019to 5 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Sport Performance at California State University, Fullerton

    Fullerton, California, 92831

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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

Being tested
Time Restricted Eating, Normal Feeding, Resistance Training, Whey Protein
Keywords
Hypertrophy, Intermittent Fasting, Time Restricted Eating, Protein Signaling, Anabolic
Medical subject headings
Hypertrophy, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time Restricted EatingOther

    Diet will be tracked and reported every day to a qualified dietitian.

  • Normal FeedingOther

    Diet will be tracked and reported every day to a qualified dietitian.

  • Resistance TrainingOther

    8 weeks of supervised and programmed whole body resistance training, performed 4x per week

  • Whey ProteinDietary supplement

    Consumed on all exercise days.

Study groups in NCT04000750
Study groupRoleWhat they receive
Time Restricted Eating (16:8)ExperimentalParticipants will consume all calories within an 8 hour window each day.
Receives: Other: Time Restricted Eating; Other: Resistance Training; Dietary Supplement: Whey Protein
ControlActive comparatorParticipants will consume all calories within a ~12 hour window each day (4 separate meals + needed snacks).
Receives: Other: Normal Feeding; Other: Resistance Training; Dietary Supplement: Whey Protein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Muscle Size - Lower Body

    via Ultrasound

    Measured: Pre, Mid (4 weeks), and Post (8 weeks)

  2. Changes in Muscle Size - Upper Body

    via Ultrasound

    Measured: Pre, Mid (4 weeks), and Post (8 weeks)

  3. Changes in Fiber Type-Specific Size

    Single muscle fiber analysis

    Measured: Pre and Post (week 8)

  4. Changes in Body composition

    via BodPod

    Measured: Pre, Mid (4 weeks), and Post (8 weeks)

  5. Acute Exercise Induced Fiber Type-Specific Anabolic Signaling (Total Concentration and Phosphorylation Status)

    Men only; assessed via single fiber Simple Western

    Measured: Day 1 of exercise training

Secondary outcomes (11)

  1. Changes in Maximal Strength

    1RM on bench press, squat, and leg extension

    Measured: Pre and Post (week 8)

  2. Changes in Maximal Muscular Endurance

    Maximal repetitions on bench press and leg press

    Measured: Pre and Post (week 8)

  3. Changes in Gut Microbiome

    via stool sample

    Measured: Pre, Mid (week 2, 4, 6), and Post (week 8)

  4. Changes in Fiber Type Composition

    Single Fiber via SDS-PAGE

    Measured: Pre and Post (week 8)

  5. Changes in Fiber Type-Specific Resting Anabolic Signaling (Total Concentration and Phosphorylation Status)

    via single fiber Simple Western

    Measured: Pre and Post (week 8)

  6. Changes in Mood

    via Questionnaire

    Measured: Weekly for duration of the intervention (8 weeks)

  7. Changes in Enjoyment of Diet

    via Questionnaire

    Measured: Weekly for duration of the intervention (8 weeks)

  8. Changes in Sleep (total and quality)

    via Questionnaire

    Measured: Weekly for duration of the intervention (8 weeks)

  9. Changes in Menstrual Cycle

    via Questionnaire; women only

    Measured: Pre, Mid (week 4), and post (week 8)

  10. Total Training Volume

    Measured: After 8 weeks

  11. Nutrient Intake

    Total Kcal and grams of protein, fat, and carbohydrates

    Measured: Daily, starting 7 days before the study and continuing for 8 additional weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2019
  2. Study start24 Jun 2019
  3. Primary completion15 Jul 2021
  4. Study completion5 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04000750
Sponsor's protocol ID
CSP Fullerton
Status last verified
Feb 2023
First submitted
25 Jun 2019
Last updated
9 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Time Restricted Eating, Normal Feeding and Resistance Training in people with Muscle Hypertrophy and Healthy and Well-Trained Men and Women, run by California State University, Fullerton at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Muscle Size - Lower Body (time frame: Pre, Mid (4 weeks), and Post (8 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04000750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.

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