Precision High-Intensity Training Through Epigenetics (PHITE)

NCT03380923 | Completed DMC

• 1 other identifier: N000141613159
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

The PHITE collaborative team, consisting of Tim Broderick, MD (Overall PI), Wright State University (WSU); Marcas Bamman, PhD (Site PI), The University of Alabama at Birmingham (UAB); and Ron Evans, PhD and Joe Ecker, PhD, Salk Institute for Biological Studies, are working with funding from the US Department of Defense (DoD), Office of Naval Research (ONR), to explore the link between physical training and epigenetics. This is a key interest area for the DoD ONR because it provides high-impact optimization of force readiness in warfighters with diverse backgrounds. The term epigenetics refers to heritable changes in gene expression (active versus inactive genes) that does not involve changes to the underlying DNA sequence; a change in phenotype (the set of observable characteristics of an individual resulting from the interaction of its genotype with the environment) without a change in genotype (the genetic constitution of an individual organism) . This in turn affects how cells read the genes. Epigenetic change is a regular and natural occurrence but can also be influenced by several factors including age, the environment/lifestyle, and disease state. Epigenetic modifications can manifest as commonly as the manner in which cells terminally differentiate to end up as skin cells, liver cells, brain cells, etc. New and ongoing research is continuously uncovering the role of epigenetics in a variety of human conditions. This study is designed to assess whether epigenetics is a primary mechanism modulating how individuals adapt to specific exercise training prescriptions designed to produce a warfighter phenotype. The PHITE team is organized around a shared test population of human subjects for which UAB will oversee recruitment, training, testing, and sampling. Healthy but untrained volunteers, both men and women, 18-27 y of age-phenotypical of the US warfighter-will participate in a 12-wk, two-arm, single-blind, randomized, exercise dose-response trial comparing two intensities of combined training: Moderate-Intensity vs. High-Intensity. Biospecimens are collected before and after an acute exercise bout in the pre-training state, and again after 12 weeks of 3 d/wk combined exercise training. Numerous phenotyping assessments are collected before after the 12-week intervention period to associate exercise training outcomes with molecular changes in the skeletal muscle and blood biospecimens.

Conditions

Healthy

Keywords

epigenetics; exercise dose-response; inter-individual response heterogeneity; exercise training adaptations

Outcome Measures

Primary Outcomes (2)

• Change in muscle mass

  Muscle mass is assessed using DXA (dual-energy X-ray absorptiometry)

  16 weeks

• Change in cardiorespiratory fitness (VO2max)

  VO2max is assessed using via indirect calorimetry during a graded cycle ergometry protocol

  16 weeks

Study Arms (2)

Moderate Intensity (MOD)

EXPERIMENTAL

Endurance Training (ET): 3 d/wk x 30 minutes (min) of steady-state, moderate-intensity exercise on a treadmill or stationary cycle ergometer at target heart rate (HR) = 65-75% of maximum oxygen consumption rate (VO2max). The two modes (treadmill, bicycle) are offered for variety, and each subject is required to use each mode at least 1 d/wk to prevent bias. Resistance training (RT): 2 d/wk consisting of a prescription engaging all major muscle groups in 10 movements. Excluding abdominal crunches, target intensity is 12 repetitions/set to volitional fatigue. Subjects complete 3 sets of each movement, with \~60 seconds (s) rest between sets. For each movement, resistance increases when 14 repetitions are achieved for 2 of 3 sets. HR is monitored throughout each session and stored for analysis.

Behavioral: Moderate Intensity

High Intensity (HI)

EXPERIMENTAL

RT: The 2 d/wk RT prescription differs from the MOD arm only in intensity and rest intervals. The same approach to progression applies, but HI RT intensity targets 8-10 repetitions per set; thus, resistance loads increase when 10 repetitions are achieved for 2 of 3 sets. The HI arm performs "superset" training, pairing movements stressing different muscle groups, with only 30-45 s between. ET: In lieu of steady-state endurance exercise, the HI arm performs high-intensity interval training (HIIT) 3 d/wk using a mix of challenging, explosive movements at maximal intensity. 10 x 30 s maximal intensity intervals are separated by 30 s rest intervals. HR is monitored throughout each session and stored for analysis.

Behavioral: High Intensity

Interventions

Moderate Intensity BEHAVIORAL

Exercise prescription intensity is moderate

Also known as: MOD

Moderate Intensity (MOD)

High Intensity BEHAVIORAL

Exercise prescription intensity is high

Also known as: HI

High Intensity (HI)

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy 18-27 year olds who are not in the US armed forces

You may not qualify if:

• History of regular endurance or resistance training in past 12 months
• BMI\>30
• Inability to tolerate intense exercise
• Diabetes
• Uncontrolled hypertension
• Unstable or exercise induced angina pectoris or myocardial ischemia
• Vascular disease
• Neurologic disease
• Musculoskeletal disorder
• Mental health disorder
• Any chronic or infectious disease that would preclude full participation
• Lidocaine allergy
• Pregnancy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Wright State University: collaborator
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

University of Alabama at Birmingham, Center for Exercise Medicine

Birmingham, Alabama, 35205, United States

Location

Study Officials

• Marcas Bamman, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors analyzing biospecimen samples are blinded to the arm to which each participant has been randomly assigned when doing analysis. Investigators are blinded to each participant's randomized assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Principle Investigator

Model Details: Randomized to moderate intensity vs. high-intensity exercise training prescription.

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 21, 2017
• Study Start: February 23, 2017
• Primary Completion: July 30, 2021
• Study Completion: July 31, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified data will be available 12 months after completion of the trial. Data will be publicly available indefinitely.

Locations

US (1)