Whole Body Vibration Combined With L-citrulline Supplementation on Cardiovascular Function and Body Composition
The Effect of Whole-body Vibration Training Combined With L-cit Supplementation on Cardiovascular, Autonomic Function and Body Composition in Postmenopausal Women
1 other identifier
interventional
60
1 country
1
Brief Summary
Arterial dysfunction contributes to the development of cardiovascular disease (CVD), which is currently afflicting millions of individuals. The use of the amino acid L-citrulline has been suggested as a potential aid for the treatment of CVD by increasing endothelial production of Nitric Oxide (NO). Whole body vibration (WBV) is new and effective form of exercise that is feasible for clinical populations and has been proven to decrease blood pressure (BP) and arterial stiffness and increase muscle mass and strength. Therefore, the purpose of this study was to investigate if the combination of WBV training (WBVT) plus L-citrulline supplementation would induce positive additive effects and would be an effective means to ameliorate arterial stiffness, endothelial function, BP and muscle strength/mass in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Mar 2013
Shorter than P25 for not_applicable obesity
1 active site
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
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 18, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedMarch 10, 2015
March 1, 2015
10 months
May 18, 2014
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Blood Pressure
Non-invasive measures of brachial and aortic blood pressure
8 weeks
Arterial Stiffness and pressure wave reflection
Using pulse wave velocity of the aorta, systemic, and legs and the augmentation index from radial tonometry
8 weeks
Endothelial and autonomic functions
By measuring circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NOx, 6-keto PGFIa, insulin, and ghrelin)and vasoconstrictors (ET-1 and 8-iso PGF2a, VEGF).In addition, heart rate variability, vascular sympathetic activity \[low-frequency power of systolic BP variability\], and spontaneous baroreflex sensitivity will be assessed from electrocardiogram and beat-by-beat digital blood pressure.
8 weeks
Secondary Outcomes (2)
Body Composition
8 weeks
Muscle Strength
8 weeks
Study Arms (4)
Control
NO INTERVENTIONThis arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 8 wk.
Whole body vibration training plus L-citrulline
EXPERIMENTALLower-body exercise training on a vibration platform combined with L-citrulline supplemetation (6 grams/day)
Whole body vibration training & placebo
EXPERIMENTALLower-body exercise training on a vibration platform combined with placebo supplementation (6 grams/day)
L-citrulline supplementation
EXPERIMENTAL(6g per day)containing L-citrulline
Interventions
The Whole body vibration training intervention consists of lower-body exercise in a vibration platform 3 times per wk for 8 wk. The subjects will perform static and dynamic exercises for the legs on the vibration platform. Dynamic exercises will be performed with slow controlled movements starting from an upright position into a 60 degree knee flexion (squat) and maximal heel elevation (toestand). Static exercises will be performed without movement in the joint angles described previously. The training volume will increase progressively over the 12-week training period by increasing the intensity of vibration, duration of the exercise set (30-60 sec), number of sets per exercise, and total duration of the training session, and decreasing the duration of rest periods (30-60 sec).The intensity of vibration and amplitude will also be increased progressively (25-30 Hz of frequency and from low to high amplitude).
Eligibility Criteria
You may qualify if:
- Female 50 to 70 years of age At least 1 year after menopause Body mass index of 27-39.9 Sedentary or low active (less than 2 hr per wk)
You may not qualify if:
- Younger than 50 or older than 70 years of age Body mass index lower than 27, or 40 or higher Physically active or competitively active Smoker Use of hormone replacement therapy of less than 1 yr Use of calcium channel blocker or beta blockers Use dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants) Uncontrolled diabetes Any restriction that would significantly interfere with compliance with the L-citrulline supplementation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida State Universitylead
- NOW Foodscollaborator
Study Sites (1)
FSU College of Human Sciences
Tallahassee, Florida, 32306, United States
Related Publications (1)
Wong A, Chernykh O, Figueroa A. Chronic l-citrulline supplementation improves cardiac sympathovagal balance in obese postmenopausal women: A preliminary report. Auton Neurosci. 2016 Jul;198:50-3. doi: 10.1016/j.autneu.2016.06.005. Epub 2016 Jun 24.
PMID: 27356482DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexei Wong
Florida State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 18, 2014
First Posted
May 21, 2014
Study Start
March 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 10, 2015
Record last verified: 2015-03