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Clinical Trials/NCT06121869
NCT06121869CompletedNot Applicable

A Pilot Study to Examine Changes in Resistance Training Adaptations After Leucine and Dileucine Ingestion

Lindenwood University2 sites in 1 country34 target enrollmentStarted: May 7, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
2
Primary Endpoint
Fat-Free Mass

Study Overview

Brief Summary

This study seeks to compare the observed changes in resistance training adaptations after supplementation of isomolar amounts of leucine or dileucine in healthy resistance-trained men. This will provide a better understanding of supplementation with leucine versus dileucine over a 10-week period in regards to increasing muscular performance.

Detailed Description

The study will be conducted using a randomized, double-blind approach with individuals being provided daily 2-gram doses of leucine, 2-gram doses of dileucine, or a placebo. Daily blinded supplementation will occur each day for a 10-week period of time while completing a heavy resistance training program. Participants follow the resistance training program for a total of 10 weeks. To compare the efficacy of leucine in form of amino acid or dipeptide supplementation on resistance training adaptations, changes in fat-free, lean, and fat mass will be determined using a 4-compartment body composition model. Skeletal muscle cross-sectional area will be assessed using ultrasound. Maximal strength, muscular endurance, and power will also be assessed. Participants will be required to provide weekly compliance and complete one supervised workout per week. After 2, 6, and 10 weeks of following the supplementation and resistance training regimens, participants will return to the laboratory to complete testing bouts consisting of identical assessments of body composition, muscular strength, muscular endurance, lower-body power, and anaerobic capacity. Adverse events related to each supplementation group will be recorded and assessed.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Masking Description

All supplements will be provided in blinded, labeled containers prior to them arriving to the site. Each supplement will be of similar volume, texture, and labeled in indistinguishable bottles to ensure blinding of both participant and invesitigator

Eligibility Criteria

Ages
18 Years to 39 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Between the ages of 18-39 years of age
  • Currently participating in resistance training exercise

Exclusion Criteria

  • Participants who are determined to not be weight stable defined as week 0 and week 2 body mass levels deviating by 3% or more.
  • Any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease.
  • Body mass index > 25 kg/m
  • Individuals with a body mass index greater than 25 kg/m2, but a body fat percentage less than 25% fat will be accepted into the study
  • Individuals who present with any previous injury or illness that would prevent them from appropriately completing all exercise lifts.
  • Participants who are not able to fit onto the DEXA table will not be able to participate in the research due to size restrictions of the equipment. This typically includes individuals exceeding 400 pounds or those greater than 6'4".
  • Those individuals with less than 12 months of structured resistance training experience will be excluded from the study.
  • Individuals whose maximal relative upper body strength is below 1.0 will be excluded.
  • Individuals whose maximal relative lower body strength is below 1.5 will be excluded.
  • All participants who DO NOT abstain from taking any additional forms of nutritional supplementation deemed to be ergogenic or that will impact resistance training adaptations (pre-workouts, creatine, beta-alanine, etc.) for four weeks prior to beginning this study and for the entire duration of the study.
  • Individuals who are currently using or have used within the past 12 months anabolic-androgenic steroids.

Outcomes

Primary Outcomes

Fat-Free Mass

Time Frame: 10 weeks

Fat-free mass will be determined via Dual-Energy X-Ray Absorptiometry

Leg Press 1RM

Time Frame: 10 weeks

Leg Press 1RM will be measured using the leg press (lower-body) exercise.

Maximal Isometric Mid-Thigh Pull Force Production

Time Frame: 10 weeks

Maximal Isometric Mid-Thigh Pull Force Production will be measured using an isometric mid-thigh pull test

Bench Press 1RM

Time Frame: 10 weeks

Bench Press 1RM will be measured using the bench press (upper-body) exercise.

Secondary Outcomes

  • Extracellular Body Water(10 weeks)
  • % Body Fat(10 weeks)
  • Leg Press Repetitions to Fatigue(10 weeks)
  • Peak Anaerobic Power(10 weeks)
  • Fat Mass(10 weeks)
  • Total body water(10 weeks)
  • Maximal Concentric Rate of Force Development(10 weeks)
  • Bench Press Repetitions to Fatigue(10 weeks)
  • Rate of Fatigue(10 weeks)
  • Lean mass(10 weeks)
  • Intracellular Body Water(10 weeks)
  • Skeletal muscle cross-sectional area(10 weeks)
  • Mean Anaerobic Power(10 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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