Dileucine and Resistance Training Adaptations

NCT ID: NCT06121869

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2023-06-29

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.

Conditions

Hypertrophy; Strength Training Adaptations; Weight-Bearing Strengthening Program

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants will supplement daily for 10 weeks with 2 grams rice flower placebo in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will supplement daily for 10 weeks with 2 grams rice flower placebo in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Leucine

Participants will supplement daily for 10 weeks with 2 grams rice leucine in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Group Type: ACTIVE_COMPARATOR

Leucine

Intervention Type: DIETARY_SUPPLEMENT

Participants will supplement daily for 10 weeks with 2 grams leucine in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Dileucine

Participants will supplement daily for 10 weeks with 2 grams dileucine (RAMPS, Ingenious Ingredients, TX, USA) in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Group Type: EXPERIMENTAL

Dileucine

Intervention Type: DIETARY_SUPPLEMENT

Participants will supplement daily for 10 weeks with 2 grams dileucine (RAMPS, Ingenious Ingredients, TX, USA) in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Interventions

Placebo

Participants will supplement daily for 10 weeks with 2 grams rice flower placebo in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Intervention Type: DIETARY_SUPPLEMENT

Leucine

Participants will supplement daily for 10 weeks with 2 grams leucine in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Intervention Type: DIETARY_SUPPLEMENT

Dileucine

Participants will supplement daily for 10 weeks with 2 grams dileucine (RAMPS, Ingenious Ingredients, TX, USA) in capsule form. On training days, participants will consume their assigned supplement within 60 minutes of completing their workout. On non-training days, participants will consume their assigned supplement with their first meal of the day. All doses will be consumed with 8-12 ounces of water.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ingenious Ingredients, L.P.

UNKNOWN

Sponsor Role: collaborator

Lindenwood University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chad M Kerksick, PhD

Role: PRINCIPAL_INVESTIGATOR

Lindenwood University

Locations

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, United States

Countries

United States

References

Hagele AM, Krieger JM, Gaige CJ, Holley KF, Gross KN, Iannotti JM, Allen LE, Sutton PJ, Orr LS, Mumford PW, Purpura M, Jager R, Kerksick CM. Dileucine ingestion, but not leucine, increases lower body strength and performance following resistance training: A double-blind, randomized, placebo-controlled trial. PLoS One. 2024 Dec 31;19(12):e0312997. doi: 10.1371/journal.pone.0312997. eCollection 2024.

Reference Type: DERIVED

PMID: 39739679 (View on PubMed)

Other Identifiers

IRB-41-64

Identifier Type: -

Identifier Source: org_study_id