NCT06121869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

November 2, 2023

Last Update Submit

November 2, 2023

Conditions

Keywords

PeptidesDipeptideAdaptationsExerciseDietary Supplements

Outcome Measures

Primary Outcomes (4)

  • Fat-Free Mass

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

    10 weeks

  • Leg Press 1RM

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

    10 weeks

  • Bench Press 1RM

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

    10 weeks

  • Maximal Isometric Mid-Thigh Pull Force Production

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

    10 weeks

Secondary Outcomes (13)

  • Fat Mass

    10 weeks

  • Lean mass

    10 weeks

  • % Body Fat

    10 weeks

  • Total body water

    10 weeks

  • Extracellular Body Water

    10 weeks

  • +8 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Leucine

ACTIVE COMPARATOR

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.

Dietary Supplement: Leucine

Dileucine

EXPERIMENTAL

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.

Dietary Supplement: Dileucine

Interventions

PlaceboDIETARY_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.

Placebo
LeucineDIETARY_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.

Leucine
DileucineDIETARY_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.

Dileucine

Eligibility Criteria

Age18 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Performance Nutrition Laboratory

Saint Charles, Missouri, 63301, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HypertrophyMotor Activity

Interventions

Leucine

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Chad M Kerksick, PhD

    Lindenwood University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, Double-Blind, Placebo-Controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

May 7, 2021

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data available to other researchers

Locations