Dileucine and Resistance Training Adaptations (DTS)

November 2, 2023 updated by: Lindenwood University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • Exercise and Performance Nutrition Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 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.
Dietary supplement: 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.
Active Comparator: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fat-Free Mass
Time Frame: 10 weeks
Fat-free mass will be determined via Dual-Energy X-Ray Absorptiometry
10 weeks
Leg Press 1RM
Time Frame: 10 weeks
Leg Press 1RM will be measured using the leg press (lower-body) exercise.
10 weeks
Bench Press 1RM
Time Frame: 10 weeks
Bench Press 1RM will be measured using the bench press (upper-body) exercise.
10 weeks
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
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fat Mass
Time Frame: 10 weeks
Fat mass will be determined via Dual-Energy X-Ray Absorptiometry
10 weeks
Lean mass
Time Frame: 10 weeks
Lean mass will be determined via Dual-Energy X-Ray Absorptiometry
10 weeks
% Body Fat
Time Frame: 10 weeks
% Body Fat will be determined via Dual-Energy X-Ray Absorptiometry
10 weeks
Total body water
Time Frame: 10 weeks
Total Body Water will be determined via bioelectrical impedance analysis
10 weeks
Extracellular Body Water
Time Frame: 10 weeks
Extracellular Body Water will be determined via bioelectrical impedance analysis
10 weeks
Intracellular Body Water
Time Frame: 10 weeks
Intracellular Body Water will be determined via bioelectrical impedance analysis
10 weeks
Skeletal muscle cross-sectional area
Time Frame: 10 weeks
Skeletal muscle cross-sectional area will be measured using ultrasound measurements of the participants thigh muscles.
10 weeks
Bench Press Repetitions to Fatigue
Time Frame: 10 weeks
Bench Press repetitions to fatigue will be measured using the bench press (upper-body) exercises on four separate occasions (visits 2, 3, 4, and 5). To complete this assessment, study participants will use a load that corresponds to 80% of their Visit 2 1RM for bench press exercise and will be instructed to complete as many repetitions as they can until failure for one set of each exercise. Failure will be defined as resting for more than two seconds throughout any point on the exercise set or technique failure.
10 weeks
Leg Press Repetitions to Fatigue
Time Frame: 10 weeks
Leg Press repetitions to fatigue will be measured using the leg press (lower-body) exercises on four separate occasions (visits 2, 3, 4, and 5). To complete this assessment, study participants will use a load that corresponds to 80% of their Visit 2 1RM for leg press exercise and will be instructed to complete as many repetitions as they can until failure for one set of each exercise. Failure will be defined as resting for more than two seconds throughout any point on the exercise set or technique failure.
10 weeks
Peak Anaerobic Power
Time Frame: 10 weeks
Peak Anaerobic Power will be measured using a Wingate Anaerobic Test lasting 30-seconds at a load set to 7.5% of week 0 body mass
10 weeks
Mean Anaerobic Power
Time Frame: 10 weeks
Mean Anaerobic Power will be measured using a Wingate Anaerobic Test lasting 30-seconds at a load set to 7.5% of week 0 body mass
10 weeks
Rate of Fatigue
Time Frame: 10 weeks
Rate of Fatigue will be measured using a Wingate Anaerobic Test lasting 30-seconds at a load set to 7.5% of week 0 body mass
10 weeks
Maximal Concentric Rate of Force Development
Time Frame: 10 weeks
Maximal concentric rate of force development will be measured using a countermovement jump performed on a force plate
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lindenwood University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ingenious Ingredients, L.P.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chad M Kerksick, PhD, Lindenwood University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-41-64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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