HypertrophyDTSNCT06121869
Dileucine and Resistance Training Adaptations
A study testing Leucine and Dileucine in people with Hypertrophy and Strength Training Adaptations, run by Lindenwood University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy, Strength Training Adaptations, Weight-Bearing Strengthening Program
- What is being tested?
- Leucine and Dileucine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2021to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Between the ages of 18-39 years of age
- Currently participating in resistance training exercise
Who cannot join
- 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".
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
Official title: 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.
Read the 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.
- Being tested
- Placebo, Leucine, Dileucine
- Keywords
- Peptides, Dipeptide, Adaptations, Exercise, Dietary Supplements
- Medical subject headings
- Hypertrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Dileucine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat-Free Mass
Fat-free mass will be determined via Dual-Energy X-Ray Absorptiometry
Measured: 10 weeks
Leg Press 1RM
Leg Press 1RM will be measured using the leg press (lower-body) exercise.
Measured: 10 weeks
Bench Press 1RM
Bench Press 1RM will be measured using the bench press (upper-body) exercise.
Measured: 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
Measured: 10 weeks
Secondary outcomes (13)
Fat Mass
Fat mass will be determined via Dual-Energy X-Ray Absorptiometry
Measured: 10 weeks
Lean mass
Lean mass will be determined via Dual-Energy X-Ray Absorptiometry
Measured: 10 weeks
% Body Fat
% Body Fat will be determined via Dual-Energy X-Ray Absorptiometry
Measured: 10 weeks
Total body water
Total Body Water will be determined via bioelectrical impedance analysis
Measured: 10 weeks
Extracellular Body Water
Extracellular Body Water will be determined via bioelectrical impedance analysis
Measured: 10 weeks
Intracellular Body Water
Intracellular Body Water will be determined via bioelectrical impedance analysis
Measured: 10 weeks
Skeletal muscle cross-sectional area
Skeletal muscle cross-sectional area will be measured using ultrasound measurements of the participants thigh muscles.
Measured: 10 weeks
Bench Press Repetitions to Fatigue
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.
Measured: 10 weeks
Leg Press Repetitions to Fatigue
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.
Measured: 10 weeks
Peak Anaerobic Power
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
Measured: 10 weeks
Mean Anaerobic Power
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
Measured: 10 weeks
Rate of Fatigue
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
Measured: 10 weeks
Maximal Concentric Rate of Force Development
Maximal concentric rate of force development will be measured using a countermovement jump performed on a force plate
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start7 May 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Collaborators
- Ingenious Ingredients, L.P.
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121869
- Sponsor's protocol ID
- IRB-41-64
- Acronym
- DTS
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data available to other researchers
Publications
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.
PubMed 39739679
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine Changes in Resistance Training Adaptations After Leucine and Dileucine Ingestion
- ClinicalTrials.gov ID
- NCT06121869
- Acronym / sponsor ID
- DTS / IRB-41-64
- Keywords
- Peptides, Dipeptide, Adaptations, Exercise, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Collaborators
- Ingenious Ingredients, L.P.
- Study start
- 7 May 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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 | Active comparator | Dietary Supplement: LeucineParticipants 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. |
| Dileucine | Experimental | Dietary Supplement: DileucineParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Between the ages of 18-39 years of age
- Currently participating in resistance training exercise
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants 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 |
| LeucineParticipants 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. | Dietary supplement | Leucine |
| DileucineParticipants 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 |
Primary outcome
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.
Bench Press 1RM
Time frame: 10 weeks
Bench Press 1RM will be measured using the bench press (upper-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
13 secondary outcomes
Fat Mass
Time frame: 10 weeks
Lean mass
Time frame: 10 weeks
% Body Fat
Time frame: 10 weeks
Total body water
Time frame: 10 weeks
Extracellular Body Water
Time frame: 10 weeks
Intracellular Body Water
Time frame: 10 weeks
Skeletal muscle cross-sectional area
Time frame: 10 weeks
Bench Press Repetitions to Fatigue
Time frame: 10 weeks
Leg Press Repetitions to Fatigue
Time frame: 10 weeks
Peak Anaerobic Power
Time frame: 10 weeks
Mean Anaerobic Power
Time frame: 10 weeks
Rate of Fatigue
Time frame: 10 weeks
Maximal Concentric Rate of Force Development
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 39739679Hagele 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.
- Individual participant dataSharing planned: No. No plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad M Kerksick, PhD principal investigator
Lindenwood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine and Dileucine in people with Hypertrophy and Strength Training Adaptations, run by Lindenwood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat-Free Mass (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023; AzTrials last refreshed its copy on 29 Oct 2026.