Skip to main content
OpenTrials
Completed

NCT Number: NCT02143817

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-Hypertension Prehypertension Signs and Symptoms Vascular Diseases

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

FSU College of Human Sciences

Tallahassee, Florida, 32306, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Citrulline supplementation

Dietary Supplement

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

Whole body vibration training

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).

Primary outcomes

  1. Blood Pressure

    Time frame: 8 weeks

    Non-invasive measures of brachial and aortic blood pressure

  2. Arterial Stiffness and pressure wave reflection

    Time frame: 8 weeks

    Using pulse wave velocity of the aorta, systemic, and legs and the augmentation index from radial tonometry

  3. Endothelial and autonomic functions

    Time frame: 8 weeks

    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 outcomes

  1. Body Composition

    Time frame: 8 weeks

    By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference

  2. Muscle Strength

    Time frame: 8 weeks

    Using eight-repetition maximum (8-RM) test for the leg press and chest press exercises

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • NOW Foods

Registry information

Official study title

The Effect of Whole-body Vibration Training Combined With L-cit Supplementation on Cardiovascular, Autonomic Function and Body Composition in Postmenopausal Women

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 21, 2014
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.