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Whole Body Vibration Combined With L-citrulline Supplementation on Cardiovascular Function and Body Composition

Primary Purpose

Obesity, Pre-hypertension, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
L-citrulline supplementation
Whole Body Vibration Training
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring whole body vibration training, L-citrulline, hypertension, obesity, arterial function, arterial stiffness, autonomic function, endothelial function

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

  • FSU College of Human Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Whole body vibration training plus L-citrulline

Whole body vibration training & placebo

L-citrulline supplementation

Arm Description

This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 8 wk.

Lower-body exercise training on a vibration platform combined with L-citrulline supplemetation (6 grams/day)

Lower-body exercise training on a vibration platform combined with placebo supplementation (6 grams/day)

(6g per day)containing L-citrulline

Outcomes

Primary Outcome Measures

Blood Pressure
Non-invasive measures of brachial and aortic blood pressure
Arterial Stiffness and pressure wave reflection
Using pulse wave velocity of the aorta, systemic, and legs and the augmentation index from radial tonometry
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.

Secondary Outcome Measures

Body Composition
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Muscle Strength
Using eight-repetition maximum (8-RM) test for the leg press and chest press exercises

Full Information

First Posted
May 18, 2014
Last Updated
March 9, 2015
Sponsor
Florida State University
Collaborators
NOW Foods
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1. Study Identification

Unique Protocol Identification Number
NCT02143817
Brief Title
Whole Body Vibration Combined With L-citrulline Supplementation on Cardiovascular Function and Body Composition
Official Title
The Effect of Whole-body Vibration Training Combined With L-cit Supplementation on Cardiovascular, Autonomic Function and Body Composition in Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
NOW Foods

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of this study is to investigate the effects of 8 weeks combination of WBVT plus L-citrulline supplementation on arterial stiffness, endothelial function, BP and muscle strength/mass in overweight/obese postmenopausal women. The specific aims of the study are: To investigate if the additive effect of 8 weeks of WBVT combined with L-citrulline supplementation are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx], 6-keto PGFIa, insulin, and ghrelin) and vasoconstrictors (endothelin-1 [ET-1],8-iso PGF2a,vascular endothelium growth factor [VGEF]) will be assessed as secondary outcome variables. To evaluate the extent to which 8 weeks of WBVT combined with L-citrulline improves body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference. To determine the additive effect of 8 weeks of WBVT combined with L-citrulline supplementation on muscle strength. These will be evaluated using the eight-repetition maximum test for the leg press and chest press exercises

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pre-hypertension, Hypertension
Keywords
whole body vibration training, L-citrulline, hypertension, obesity, arterial function, arterial stiffness, autonomic function, endothelial function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 8 wk.
Arm Title
Whole body vibration training plus L-citrulline
Arm Type
Experimental
Arm Description
Lower-body exercise training on a vibration platform combined with L-citrulline supplemetation (6 grams/day)
Arm Title
Whole body vibration training & placebo
Arm Type
Experimental
Arm Description
Lower-body exercise training on a vibration platform combined with placebo supplementation (6 grams/day)
Arm Title
L-citrulline supplementation
Arm Type
Experimental
Arm Description
(6g per day)containing L-citrulline
Intervention Type
Dietary Supplement
Intervention Name(s)
L-citrulline supplementation
Other Intervention Name(s)
8 weeks of L-citrulline supplementation in two doses of 3g each per day (6g per day)
Intervention Type
Other
Intervention Name(s)
Whole Body Vibration Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Non-invasive measures of brachial and aortic blood pressure
Time Frame
8 weeks
Title
Arterial Stiffness and pressure wave reflection
Description
Using pulse wave velocity of the aorta, systemic, and legs and the augmentation index from radial tonometry
Time Frame
8 weeks
Title
Endothelial and autonomic functions
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Body Composition
Description
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Time Frame
8 weeks
Title
Muscle Strength
Description
Using eight-repetition maximum (8-RM) test for the leg press and chest press exercises
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexei Wong
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
FSU College of Human Sciences
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27356482
Citation
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.
Results Reference
derived

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Whole Body Vibration Combined With L-citrulline Supplementation on Cardiovascular Function and Body Composition

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