NCT02143817

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

May 18, 2014

Last Update Submit

March 9, 2015

Conditions

Keywords

whole body vibration trainingL-citrullinehypertensionobesityarterial functionarterial stiffnessautonomic functionendothelial function

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 INTERVENTION

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.

Whole body vibration training plus L-citrulline

EXPERIMENTAL

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

Dietary Supplement: L-citrulline supplementationOther: Whole Body Vibration Training

Whole body vibration training & placebo

EXPERIMENTAL

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

Other: Whole Body Vibration Training

L-citrulline supplementation

EXPERIMENTAL

(6g per day)containing L-citrulline

Dietary Supplement: L-citrulline supplementation

Interventions

Also known as: 8 weeks of L-citrulline supplementation in two doses of 3g each per day (6g per day)
L-citrulline supplementationWhole body vibration training plus L-citrulline

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 & placeboWhole body vibration training plus L-citrulline

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

FSU College of Human Sciences

Tallahassee, Florida, 32306, United States

Location

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.

MeSH Terms

Conditions

ObesityPrehypertensionHypertension

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Alexei Wong

    Florida State University

    PRINCIPAL INVESTIGATOR

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

Locations