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

NCT ID: NCT02143817

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-01-31

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:

1. 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.

2. 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.

3. 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

Conditions

Obesity; Pre-hypertension; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Whole body vibration training plus L-citrulline

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

Group Type: EXPERIMENTAL

L-citrulline supplementation

Intervention Type: DIETARY_SUPPLEMENT

Whole Body Vibration Training

Intervention Type: OTHER

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).

Whole body vibration training & placebo

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

Group Type: EXPERIMENTAL

Whole Body Vibration Training

Intervention Type: OTHER

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).

L-citrulline supplementation

(6g per day)containing L-citrulline

Group Type: EXPERIMENTAL

L-citrulline supplementation

Intervention Type: DIETARY_SUPPLEMENT

Interventions

L-citrulline supplementation

Intervention Type: DIETARY_SUPPLEMENT

Whole Body Vibration Training

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).

Intervention Type: OTHER

Other Intervention Names

8 weeks of L-citrulline supplementation in two doses of 3g each per day (6g per day)

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NOW Foods

OTHER

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Arturo Figueroa

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexei Wong

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

FSU College of Human Sciences

Tallahassee, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27356482 (View on PubMed)

Other Identifiers

HSC2012.9674

Identifier Type: -

Identifier Source: org_study_id