Blood Flow Restriction TrainingNCT05790070
Potential Synergistic Effect of Combined Blood Flow Restriction Training and Betaine Supplementation on Skeletal Muscle
A study testing Betaine in people with Blood Flow Restriction Training and Betaine Supplementation, run by Baylor University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether there is a synergistic effect via combining both low-load blood flow restriction (BFR) training and betaine supplementation loading (6g/day for 14 days) on skeletal muscle anabolic signaling pathways that is mediated by enhancements in intracellular water. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction Training, Betaine Supplementation
- What is being tested?
- Betaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Jul 2021
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only participants considered low risk for cardiovascular disease with no contraindications to exercise as outlined by the ACSM
- Have not consumed any nutritional supplements (aside from a multi-vitamin) one month prior to investigation
- Blood pressure <140/90mmHg
- Resting heart rate <90bpm-
Who cannot join
- sedentary individual as defined by the ACSM guidelines.
- inadequate resistance training experience (<12 months, <3x/week)
- vegetarian, vegan, or have dietary restrictions or supplements that potentially affect betaine metabolism.
- allergy to topical anesthetics.
- known metabolic or cardiovascular disorder including heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism.
- genetic disorders/polymorphisms that would act as direct contraindications to betaine supplementation (i.e. methyltetrahydrofolate reductase, hyperhomocysteinemia, etc.)
Show all 10Show fewer
- bleeding disorder, history of pulmonary disease, hypertension, hepatorenal disease, musculoskeletal disorders, neuromuscular/ neurological diseases, autoimmune disease, cancer, peptic ulcers, anemia, or chronic infection (e.g., HIV).
- resting systolic/diastolic blood pressure and heart rate of more than 140/90 mmHg and 90, respectively.
- taking any blood thinning (e.g., warfarin, Jantoven, etc.), heart, pulmonary, thyroid, anti-hyperlipidemic, hypoglycemic, anti-hypertensive, endocrinologic (e.g, thyroid, insulin, etc), emotional/psychotropic (e.g., Prednisone, Ritalin, Adderall), or neuromuscular/neurological medications.
- taking anabolic androgenic steroids within the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Synergistic Effect of Combined Blood Flow Restriction Training and Betaine Supplementation on Skeletal Muscle Mechanotransduction-Associated Cell Signaling
The purpose of the study is to determine whether there is a synergistic effect via combining both low-load blood flow restriction (BFR) training and betaine supplementation loading (6g/day for 14 days) on skeletal muscle anabolic signaling pathways that is mediated by enhancements in intracellular water. These effects are proposed to be greater than either BFR training or betaine supplementation alone or compared to control conditions (high-load non-occluded and/or placebo supplementation).
Read the detailed description
The purpose of the investigation is to determine whether the combination of blood flow restriction (BFR) training and betaine supplementation can synergistically augment phosphorylated targets associated with mechanotransduction and/or muscle protein synthesis relative to either modality alone and compared against control conditions (standard "high-intensity" resistance training and placebo supplementation) in healthy young males. Secondly, the investigators aim to determine if any potential synergistic effects are mediated by enhanced intracellular fluid volumes, as determined by the changes in water content between hydrated and dehydrated muscle samples, as well as through changes in both muscle and serum betaine concentrations. Finally, the investigators aim to assess differences in the aforementioned interventions on specific gene targets, the betaine/γ-aminobutyric acid transporter, myosin heavy chain I, IIa, and IIx lactate dehydrogenase A. Therefore, the specific aims of this study are to determine in healthy, young males: 1) whether combined BFR training and betaine supplementation significantly augment mechanotransductive growth-associated post-translational protein modifications via extra-to-intracellular fluid flux, alongside 2) potentially altered gene expression that otherwise characterizes phenotypical/biochemical changes in skeletal muscle.
The specific aims of the study are to determine whether:
- The combination of BFR training and betaine supplementation demonstrates significantly greater phosphorylated FAK, ERK1/2, IRS1, and p70S6K, commensurate with greater wet-to-dry hydration changes, relative to any other combinations between BFR training, standard "high-load" training, betaine supplementation, and/or placebo ingestion.
- The combination of BFR training and betaine supplementation will result in increased MYH2 gene expression, alongside decreases in MYH7 and MYH1 expression. Furthermore, this combination will also result in the highest degree of HIF-1 and Ldha, as well as the lowest BGT-1 gene expression relative to baseline levels.
- The combination of BFR training and betaine supplementation will result in a higher load-volume accumulated relative to BFR-alone, and will not be statistically different than high-load-placebo training. Therein, the high-load-betaine group will have the greatest load-volume amidst any other combination of conditions.
- Being tested
- Betaine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetaineDietary supplement
3g/ twice daily (separated by ~12 hours) betaine anhydrous
PlaceboOther
3g/ twice daily (separated by ~12 hours) cellulose placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 3g/ twice daily (separated by ~12 hours) cellulose placebo for 14 days Receives: Other: Placebo |
| Betaine Supplementation | Experimental | 3g/twice daily (separated by ~12 hours) betaine anhydrous for 14 days Receives: Dietary Supplement: Betaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum/muscle phosphorylated FAK
Focal adhesion kinase
Measured: 3 hours following exercise cessation
insulin receptor substrate 1
signalling adapter protein
Measured: 3 hours following exercise cessation
gene expression of HIF-1
genes related to skeletal muscle adaptation
Measured: 3 hours following exercise cessation
serum and muscle betaine concentrations
measure related to the supplementation protocol
Measured: 3 hours following exercise cessation
gene expression BGT-1
genes related to skeletal muscle adaptation
Measured: 3 hours following exercise cessation
gene expression MHC
genes related to skeletal muscle adaptation
Measured: 3 hours following exercise cessation
Secondary outcomes (4)
pre-to-post exercise set tissue hydration
hydration status of the participant via multi-frequency bioelectrical impedance
Measured: both pre and immediately post exercise session
capillary blood lactate concentrations
blood lactate levels of the participant
Measured: both pre and immediately post exercise session
set-to-failure repetition number
as related to the exercise protocol
Measured: immediately post exercise session
exercise condition total load-volume.
as related to the exercise protocol and calculated at termination of the exercise session
Measured: immediately post exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Feb 2021
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction TrainingStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LesLee Funderburk, PhD, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790070
- Sponsor's protocol ID
- 1676709-6
- Status last verified
- Mar 2023
- First submitted
- 20 Oct 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Synergistic Effect of Combined Blood Flow Restriction Training and Betaine Supplementation on Skeletal Muscle Mechanotransduction-Associated Cell Signaling
- ClinicalTrials.gov ID
- NCT05790070
- Acronym / sponsor ID
- 1676709-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 29 Mar 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.
The purpose of the study is to determine whether there is a synergistic effect via combining both low-load blood flow restriction (BFR) training and betaine supplementation loading (6g/day for 14 days) on skeletal muscle anabolic signaling pathways that is mediated by enhancements in intracellular water. These effects are proposed to be greater than either BFR training or betaine supplementation alone or compared to control conditions (high-load non-occluded and/or placebo supplementation).
Detailed description
The purpose of the investigation is to determine whether the combination of blood flow restriction (BFR) training and betaine supplementation can synergistically augment phosphorylated targets associated with mechanotransduction and/or muscle protein synthesis relative to either modality alone and compared against control conditions (standard "high-intensity" resistance training and placebo supplementation) in healthy young males. Secondly, the investigators aim to determine if any potential synergistic effects are mediated by enhanced intracellular fluid volumes, as determined by the changes in water content between hydrated and dehydrated muscle samples, as well as through changes in both muscle and serum betaine concentrations. Finally, the investigators aim to assess differences in the aforementioned interventions on specific gene targets, the betaine/γ-aminobutyric acid transporter, myosin heavy chain I, IIa, and IIx lactate dehydrogenase A. Therefore, the specific aims of this study are to determine in healthy, young males: 1) whether combined BFR training and betaine supplementation significantly augment mechanotransductive growth-associated post-translational protein modifications via extra-to-intracellular fluid flux, alongside 2) potentially altered gene expression that otherwise characterizes phenotypical/biochemical changes in skeletal muscle.
The specific aims of the study are to determine whether:
- The combination of BFR training and betaine supplementation demonstrates significantly greater phosphorylated FAK, ERK1/2, IRS1, and p70S6K, commensurate with greater wet-to-dry hydration changes, relative to any other combinations between BFR training, standard "high-load" training, betaine supplementation, and/or placebo ingestion.
- The combination of BFR training and betaine supplementation will result in increased MYH2 gene expression, alongside decreases in MYH7 and MYH1 expression. Furthermore, this combination will also result in the highest degree of HIF-1 and Ldha, as well as the lowest BGT-1 gene expression relative to baseline levels.
- The combination of BFR training and betaine supplementation will result in a higher load-volume accumulated relative to BFR-alone, and will not be statistically different than high-load-placebo training. Therein, the high-load-betaine group will have the greatest load-volume amidst any other combination of conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo3g/ twice daily (separated by ~12 hours) cellulose placebo for 14 days |
| Betaine Supplementation | Experimental | Dietary Supplement: Betaine3g/twice daily (separated by ~12 hours) betaine anhydrous for 14 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Only participants considered low risk for cardiovascular disease with no contraindications to exercise as outlined by the ACSM
- Have not consumed any nutritional supplements (aside from a multi-vitamin) one month prior to investigation
- Blood pressure <140/90mmHg
- Resting heart rate <90bpm-
Key exclusion criteria (10 listed)
- sedentary individual as defined by the ACSM guidelines.
- inadequate resistance training experience (<12 months, <3x/week)
- vegetarian, vegan, or have dietary restrictions or supplements that potentially affect betaine metabolism.
- allergy to topical anesthetics.
- known metabolic or cardiovascular disorder including heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism.
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 |
|---|---|---|
| Betaine3g/ twice daily (separated by ~12 hours) betaine anhydrous | Dietary supplement | Betaine Supplementation |
| Placebo3g/ twice daily (separated by ~12 hours) cellulose placebo | Other | Placebo |
Primary outcome
serum/muscle phosphorylated FAK
Time frame: 3 hours following exercise cessation
Focal adhesion kinase
insulin receptor substrate 1
Time frame: 3 hours following exercise cessation
signalling adapter protein
gene expression of HIF-1
Time frame: 3 hours following exercise cessation
genes related to skeletal muscle adaptation
serum and muscle betaine concentrations
Time frame: 3 hours following exercise cessation
measure related to the supplementation protocol
gene expression BGT-1
Time frame: 3 hours following exercise cessation
genes related to skeletal muscle adaptation
gene expression MHC
Time frame: 3 hours following exercise cessation
genes related to skeletal muscle adaptation
4 secondary outcomes
pre-to-post exercise set tissue hydration
Time frame: both pre and immediately post exercise session
capillary blood lactate concentrations
Time frame: both pre and immediately post exercise session
set-to-failure repetition number
Time frame: immediately post exercise session
exercise condition total load-volume.
Time frame: immediately post exercise session
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 29 Mar 2023.
- Individual participant dataSharing planned: No
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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.
LesLee Funderburk, PhD principal investigator
Baylor 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 Betaine in people with Blood Flow Restriction Training and Betaine Supplementation, run by Baylor 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 4 inclusion and 10 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 29 Mar 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?
serum/muscle phosphorylated FAK (time frame: 3 hours following exercise cessation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2023.