NCT05790070

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

October 20, 2022

Last Update Submit

March 28, 2023

Conditions

Blood Flow Restriction TrainingBetaine Supplementation

Outcome Measures

Primary Outcomes (6)

  • serum/muscle phosphorylated FAK

    Focal adhesion kinase

    3 hours following exercise cessation

  • insulin receptor substrate 1

    signalling adapter protein

    3 hours following exercise cessation

  • gene expression of HIF-1

    genes related to skeletal muscle adaptation

    3 hours following exercise cessation

  • serum and muscle betaine concentrations

    measure related to the supplementation protocol

    3 hours following exercise cessation

  • gene expression BGT-1

    genes related to skeletal muscle adaptation

    3 hours following exercise cessation

  • gene expression MHC

    genes related to skeletal muscle adaptation

    3 hours following exercise cessation

Secondary Outcomes (4)

  • pre-to-post exercise set tissue hydration

    both pre and immediately post exercise session

  • capillary blood lactate concentrations

    both pre and immediately post exercise session

  • set-to-failure repetition number

    immediately post exercise session

  • exercise condition total load-volume.

    immediately post exercise session

Study Arms (2)

Placebo

PLACEBO COMPARATOR

3g/ twice daily (separated by \~12 hours) cellulose placebo for 14 days

Other: Placebo

Betaine Supplementation

EXPERIMENTAL

3g/twice daily (separated by \~12 hours) betaine anhydrous for 14 days

Dietary Supplement: Betaine

Interventions

BetaineDIETARY_SUPPLEMENT

3g/ twice daily (separated by \~12 hours) betaine anhydrous

Betaine Supplementation
PlaceboOTHER

3g/ twice daily (separated by \~12 hours) cellulose placebo

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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-

You may not qualify if:

  • 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.)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

MeSH Terms

Interventions

Betaine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • LesLee Funderburk, PhD

    Baylor University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

March 29, 2023

Study Start

February 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)