Clinical trial NCT06121869: Dileucine and Resistance Training Adaptations
Official title: A Pilot Study to Examine Changes in Resistance Training Adaptations After Leucine and Dileucine Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophy
Strength Training Adaptations
Weight-Bearing Strengthening Program
Keywords: Peptides
Dipeptide
Adaptations
Exercise
Dietary Supplements
Lead sponsor: Lindenwood University
Sponsor class: OTHER
Collaborators: name: Ingenious Ingredients, L.P.
First posted: 2023-11-08
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Female
* 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/m2. 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.

Primary outcomes:
measure: Fat-Free Mass
timeFrame: 10 weeks
measure: Leg Press 1RM
timeFrame: 10 weeks
measure: Bench Press 1RM
timeFrame: 10 weeks
measure: Maximal Isometric Mid-Thigh Pull Force Production
timeFrame: 10 weeks
Secondary outcomes:
measure: Fat Mass
timeFrame: 10 weeks
measure: Lean mass
timeFrame: 10 weeks
measure: % Body Fat
timeFrame: 10 weeks
measure: Total body water
timeFrame: 10 weeks
measure: Extracellular Body Water
timeFrame: 10 weeks
measure: Intracellular Body Water
timeFrame: 10 weeks
measure: Skeletal muscle cross-sectional area
timeFrame: 10 weeks
measure: Bench Press Repetitions to Fatigue
timeFrame: 10 weeks
measure: Leg Press Repetitions to Fatigue
timeFrame: 10 weeks
measure: Peak Anaerobic Power
timeFrame: 10 weeks
measure: Mean Anaerobic Power
timeFrame: 10 weeks
measure: Rate of Fatigue
timeFrame: 10 weeks
measure: Maximal Concentric Rate of Force Development
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Exercise and Performance Nutrition Laboratory
state: Missouri
Study officials:
affiliation: Lindenwood University
name: Chad M Kerksick, PhD
role: PRINCIPAL_INVESTIGATOR
References: